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Clinical Trials/NCT02475031
NCT02475031
Completed
Phase 4

Randomized, Prospective, Double Blind Study Comparing Single Shot Versus Continuous Transverses Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Live Donor Nephrectomy

Indiana University1 site in 1 country70 target enrollmentJuly 2012
InterventionsTAP-STAP-C
DrugsTAP-S

Overview

Phase
Phase 4
Intervention
TAP-S
Conditions
Postoperative Pain
Sponsor
Indiana University
Enrollment
70
Locations
1
Primary Endpoint
Total Narcotic Usage at 48 Hours
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to determine whether continuous transversus abdominis plane (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor nephrectomy

Detailed Description

This study is a randomized, prospective, double blind study comparing single shot versus continuous transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic live donor nephrectomy. Good pain control after surgery has been shown to decrease complications. To address the problem of postoperative pain control in donor nephrectomy patients,the study investigators began performing Transversus Abdominis Plane (TAP) blocks. The TAP block involves injection of local anesthetic between the abdominal muscle planes (internal oblique muscle and transversus abdominis muscle), to block the somatic nerves that supply sensation to the skin, muscles, and parietal peritoneum of the anterior abdominal wall. Prior reports of TAP blocks have shown that it provides good analgesia for postoperative pain after abdominal surgery. However because the duration of postoperative pain exceeds that of the single shot TAP block, the investigators hypothesized that by placing a catheter through which a continuous infusion of local anesthetic could be delivered, investigators could provide analgesia throughout the postoperative period. The study investigators also hypothesized that improved analgesia would decrease the need for opioid pain medications, hence decreasing the side effects associated with opioid use. This study is designed to test our hypothesis that placing a TAP catheter is superior to single shot TAP, because it provides a longer duration of analgesia and decreases narcotic use.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
December 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yar Yeap

Assistant Professor of Clinical Anesthesia

Indiana University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Placebo Group (TAP-S)

(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter

Intervention: TAP-S

Active Group (TAP-C)

(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter

Intervention: TAP-C

Outcomes

Primary Outcomes

Total Narcotic Usage at 48 Hours

Time Frame: 48 hours

The primary endpoint of this study will be narcotic requirement at 48 hours

Secondary Outcomes

  • Sedation Scores at 48 Hours(48 hours)
  • Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours(up to 60 hours)
  • Average Pain Scores(up to 60 hours)
  • Nausea Scores at 48 Hours(up to 48 hours)

Study Sites (1)

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