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Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02164929
Recruitment Status : Terminated (Poor recruitment)
First Posted : June 17, 2014
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Laparoscopic Colorectal Resection
Interventions Procedure: TAP block
Procedure: Epidural
Procedure: Paravertebral block
Drug: Acetaminophen 1g IV
Drug: Dexamethasone 4mg
Drug: Midazolam up to 2mg
Drug: Propofol 1-2.5 mg/kg
Drug: Sevoflurane to keep a bispectral index of between 40-60
Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%
Drug: Lidocaine
Drug: Epinephrine
Drug: Hydromorphone
Enrollment 17
Recruitment Details  
Pre-assignment Details Of the 17 patients that consented, one patient withdrew before randomization
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Period Title: Overall Study
Started 4 3 5 4
Completed 3 3 4 2
Not Completed 1 0 1 2
Reason Not Completed
Converted to open procedure             1             0             0             2
Failed regional block             0             0             1             0
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone) Total
Hide Arm/Group Description

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Total of all reporting groups
Overall Number of Baseline Participants 4 3 4 4 15
Hide Baseline Analysis Population Description
Participants that completed the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 4 participants 4 participants 15 participants
55.5  (8.5) 51  (15) 57.75  (6.6) 52  (21.9) 54.2  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 4 participants 4 participants 15 participants
Female
2
  50.0%
1
  33.3%
2
  50.0%
2
  50.0%
7
  46.7%
Male
2
  50.0%
2
  66.7%
2
  50.0%
2
  50.0%
8
  53.3%
1.Primary Outcome
Title Postoperative Opioid Consumption
Hide Description If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.
Time Frame 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description:

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Overall Number of Participants Analyzed 3 3 4 2
Mean (Standard Deviation)
Unit of Measure: mcg
734  (422) 666  (474) 125  (50) 1017.5  (484)
2.Secondary Outcome
Title Pain Scores
Hide Description Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where "0" represents no pain and "10" represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated.
Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description:

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Overall Number of Participants Analyzed 3 3 4 2
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.66  (1.15) 2.66  (1.52) 1.75  (1.25) 6  (2.82)
3.Secondary Outcome
Title Quality of Recovery
Hide Description Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description:

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Overall Number of Participants Analyzed 3 3 4 2
Mean (Standard Deviation)
Unit of Measure: Units on a scale
89.5  (10.6) 117  (23.3) 115.5  (0.7) 99  (17.6)
4.Secondary Outcome
Title Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)
Hide Description Complications using a Modified Postoperative Morbidity Survey (MPMS)
Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description:

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to First Bowel Movement
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description:

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Overall Number of Participants Analyzed 3 3 4 2
Mean (Standard Deviation)
Unit of Measure: days
1  (1.4) 2  (0.7) 1  (0.8) 2  (0)
6.Secondary Outcome
Title Opioid Related Side Effects
Hide Description Occurrence and duration of opioid related adverse events including postoperative nausea and vomiting (PONV); pruritus, urinary retention, confusion, sedation and respiratory depression at the above time points.
Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description:

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Overall Number of Participants Analyzed 3 3 4 2
Measure Type: Number
Unit of Measure: side effects
0 0 0 0
7.Secondary Outcome
Title Time to First Ingestion of Solid Food
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description:

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Overall Number of Participants Analyzed 3 3 4 2
Mean (Standard Deviation)
Unit of Measure: Days
1  (0) 2  (0.7) 0.75  (0.5) 1.5  (0.7)
8.Secondary Outcome
Title Number of Epidural-related Side Effects
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description:

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Overall Number of Participants Analyzed 3 3 4 2
Measure Type: Number
Unit of Measure: Number of side effects
0 0 0 0
9.Secondary Outcome
Title Length of Stay
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description:

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Overall Number of Participants Analyzed 3 3 4 2
Mean (Standard Deviation)
Unit of Measure: Days
2.66  (0.57) 4.33  (3.21) 4  (1.41) 3.5  (0.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Hide Arm/Group Description

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Paravertebral block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

TAP block

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

Epidural

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropi

Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

Acetaminophen 1g IV

Dexamethasone 4mg

Midazolam up to 2mg

Propofol 1-2.5 mg/kg

Sevoflurane to keep a bispectral index of between 40-60

Local infiltration with 10 mL of plain ropivacaine 0.25%

All-Cause Mortality
Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paravertebral Block TAP Block Epidural No Block (PCA Alone)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Timothy Miller, MD
Organization: Duke University Medical Center
EMail: timothy.miller2@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02164929    
Other Study ID Numbers: Pro00047810
First Submitted: June 11, 2014
First Posted: June 17, 2014
Results First Submitted: July 24, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017