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Clinical Trials/NCT03080142
NCT03080142
Completed
Phase 4

Transversus Abdominus Plane (TAP) Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery: A Prospective Randomized Control Trial

University of California, Davis1 site in 1 country86 target enrollmentMarch 1, 2017

Overview

Phase
Phase 4
Intervention
Exparel
Conditions
Colorectal Surgery
Sponsor
University of California, Davis
Enrollment
86
Locations
1
Primary Endpoint
Mean Opioid Consumption in Morphine Opioid Equivalents in mg
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This is a prospective randomized study designed to compare the pain control from a single shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters with ropivicaine bolus in patients undergoing elective colorectal surgery.

Detailed Description

At UC Davis, it is standard practice to place TAP blocks with catheters for adult colorectal surgery patients for perioperative pain control. This practice, however, is resource intensive, adds the risk of catheter-related complications, and adds increased burden to patients by requiring them to be tethered to 2 catheters. An alternative TAP can be performed using a single shot of liposomal bupivacaine (Exparel), an extended release local anesthetic that is FDA-approved for surgical plane infiltration including TAP blocks. With this prospective study, we seek to improve patient care at UC Davis and educate other institutions through the use of concrete data comparing these 2 treatment options.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
May 29, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for elective colorectal surgery with Dr. Linda Farkas

Exclusion Criteria

  • Patients under 18 years of age
  • Patient over 90 years of age
  • Pregnancy
  • Prisoners
  • Patients unable to provide consent
  • Patients on systemic anticoagulation therapy
  • Patients with an allergy to local anesthetics

Arms & Interventions

Group 1

Single injection of Exparel

Intervention: Exparel

Group 2

Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Mean Opioid Consumption in Morphine Opioid Equivalents in mg

Time Frame: 48 hours from start of surgery

Anticipate superior efficacy and pain control with liposomal bupivacaine TAP blocks measured by use of opioids (measured in oral morphine equivalents) in the first 48 hours following surgery Will use opioid consumption in morphine equivalents as a comparison

Study Sites (1)

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