ClinicalTrials.gov
ClinicalTrials.gov Menu

Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement

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: NCT02161484
Recruitment Status : Terminated (The computer is crushed and all data is lost (IT was not able to recover it. Last data was collected 6.17.14))
First Posted : June 11, 2014
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Rita Merman, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Osteoarthritis of Hip
Regional Anesthesia
Other Acute Postoperative Pain
Total Hip Arthroplasty
Peripheral Nerve Block
Lumbar Plexus Nerve Block
Parasacaral (Sciatic) Nerve Block
Interventions Procedure: Continuous Lumbar Plexus Block
Procedure: Parasacral Nerve Block
Drug: Ropivacine 0.2%
Drug: Bupivacaine 0.0625%
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Period Title: Overall Study
Started 5 5
Completed 1 2
Not Completed 4 3
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block Total
Hide Arm/Group Description

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
56.8  (2.86) 58.6  (7.67) 57.7  (5.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
2
  40.0%
4
  80.0%
6
  60.0%
Male
3
  60.0%
1
  20.0%
4
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
5
 100.0%
5
 100.0%
10
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
5
 100.0%
10
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Numeric Rating Scale (NRS) Pain Assessment
Hide Description Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Time Frame 6 hours after the start of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description:

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain at Rest 2.6  (2.19) 3.6  (1.67)
Pain with Movement 3.5  (1.67) 5  (1.87)
2.Primary Outcome
Title Numeric Rating Scale (NRS) Pain Assessment
Hide Description Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Time Frame 24 hours after the start of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description:

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain at Rest 4.25  (2.75) 2.2  (1.92)
Pain with Movement 7.25  (2.5) 4.4  (0.89)
3.Primary Outcome
Title Numeric Rating Scale (NRS) Pain Assessment
Hide Description Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Time Frame 48 hours after the start of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description:

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Overall Number of Participants Analyzed 1 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain at Rest 1  (0) 2  (1.14)
Pain with Movement 8  (0) 5  (1.41)
4.Secondary Outcome
Title Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively
Hide Description [Not Specified]
Time Frame 48 hours after the start of the surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description:

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Amount of Oxycodone for the First 48 h Post Operatively
Hide Description Including number of dose and mg).
Time Frame 48 hours after the start of the surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description:

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively
Hide Description [Not Specified]
Time Frame 48 hours after the start of the surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description:

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively
Hide Description [Not Specified]
Time Frame 48 hours after the start of the surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description:

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Total Amount of Local Anesthetic in 48 Hours Post Operatively
Hide Description Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)
Time Frame 48 hours after the start of the surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description:

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Incidence of Complications (e.g. Frequency of Foot-drop).
Hide Description Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, “Foot Drop”, allergic reaction will be recorded
Time Frame 48 hours after the start of the surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description:

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: Number of complications
0 0
Time Frame From enrollment until 48 hours post-operatively or discharge from the hospital, whichever occurs first
Adverse Event Reporting Description In addition to regular monitoring, questionnaires were given at 48 hours post-operatively to assess drug toxicity signs such as: numbness, ringing in ears, vision problems, motor weakness, metallic taste, etc.
 
Arm/Group Title Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Hide Arm/Group Description

Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Arm: Active Comparator: Lumbar Plexus Nerve Block

Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.

No sham/placebo parasacral (sciatic) blocks will be performed in this group.

All-Cause Mortality
Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Lumbar Plexus Block With Parasacral Nerve Block Lumbar Plexus Nerve Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Rita Merman, P.I.
Organization: University of Pittsburgh
Phone: 41256322137
Responsible Party: Rita Merman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02161484     History of Changes
Other Study ID Numbers: PRO13030184
First Submitted: June 2, 2014
First Posted: June 11, 2014
Results First Submitted: January 31, 2018
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018