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

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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

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 17, 2014
Results First Submitted Date  ICMJE July 24, 2017
Results First Posted Date  ICMJE September 25, 2017
Last Update Posted Date September 25, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
Postoperative Opioid Consumption [ Time Frame: 24 hours after surgery ]
If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
Postoperative Opioid Consumption [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
Opioid consumption at 30, 60, 90, 120 min, every 6 hours for 24 hours and at 48 and 72 hours or until discharge. If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • Pain Scores [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
    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.
  • Quality of Recovery [ Time Frame: 72 hours ]
    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.
  • Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS) [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
    Complications using a Modified Postoperative Morbidity Survey (MPMS)
  • Time to First Bowel Movement [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
  • Opioid Related Side Effects [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
    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 to First Ingestion of Solid Food [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
  • Number of Epidural-related Side Effects [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
  • Length of Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
  • Pain Scores [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
    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.
  • Quality of Recovery [ Time Frame: 72 hours ]
    Quality of Recovery 15 (QoR-15) score once a day for 72 hours
  • Complications [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
    Complications using a Modified Postoperative Morbidity Survey (MPMS)
  • First bowel movement [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
  • Opioid Related Side Effects [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
    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.
  • First ingestion of solid food [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy
Official Title  ICMJE A Prospective, Randomized, Single-Blind Study to Evaluate the Efficacy of Transversus Abdominis Plane Versus Paravertebral Regional Blockade in Patients Undergoing Laparoscopic Colectomy
Brief Summary The purpose of this study is to assess the effectiveness of transversus abdominal plane (TAP) block, thoracic epidural or paravertebral block (PVB) for controlling postoperative pain when compared with opioid you self-administer in your vein using a PCA device. The primary outcome will be postoperative opioid consumption within 24 hours after surgery. A total of 120 subjects will be randomized in a 1:1:1:1 ratio to receive a TAP block, PVB, TEA or no block (PCA alone).Patients in all groups will be cared for using an established enhanced recovery after surgery (ERAS) pathway incorporating a multimodal analgesic regimen using IV acetaminophen and postoperative PCA fentanyl.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Laparoscopic Colorectal Resection
Intervention  ICMJE
  • Procedure: TAP block
    Other Name: Transversus abdominus plane block
  • Procedure: Epidural
    Other Name: Thoracic Epidural Anesthesia (TEA)
  • Procedure: Paravertebral block
    Other Name: PVB
  • 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
    1.5% lidocaine
  • Drug: Epinephrine
    1:200,000 epinephrine
  • Drug: Hydromorphone
    400-800 mcg Hydromorphone will be given preoperatively
Study Arms  ICMJE
  • Active Comparator: Paravertebral block
    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).
    Interventions:
    • 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%
  • Active Comparator: TAP block
    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).
    Interventions:
    • Procedure: TAP 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%
  • Active Comparator: Epidural

    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.

    Interventions:
    • Procedure: Epidural
    • 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
  • Active Comparator: No block (PCA alone)
    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
    Interventions:
    • 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%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 25, 2017)
17
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2014)
120
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Male or female, ≥ 18 years of age
  • Patients scheduled to undergo laparoscopic colectomy without stoma under general anesthesia
  • American Society of Anesthesiology (ASA) Physical Class 1-3.

Exclusion Criteria:

  • Open colectomy
  • Perineal resection
  • Stoma formation
  • Patients with a contraindication to TEA or regional anesthesia.
  • Pregnancy, nursing, or planning to become pregnant during the study or within one month.
  • Long-acting opioid medication within 3 days.
  • Any opioid medication within 24 hours.
  • Body weight less than 50 kilograms (~110 pounds)
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder
  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.
  • Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
  • Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  • Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, severe renal impairment, advanced diabetes, comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02164929
Other Study ID Numbers  ICMJE Pro00047810
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP