TAP Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery

Phase 4

Completed

• Conditions: Colorectal Surgery; TAP Blocks
• Interventions: Drug: Exparel; Drug: Ropivacaine

• Registration Number: NCT03080142
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Primary Completion: 2019-05-29
• Study Completion: 2019-05-29
• Results First Submitted: 2020-11-16
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-01
• Last Update Submitted: 2021-04-01
• Results First Posted: 2021-04-27
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Exparel	Single injection of Exparel
Group 2	Ropivacaine	Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters

Primary Outcome Measures

Name	Time	Method
Mean Opioid Consumption in Morphine Opioid Equivalents in mg	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

Trial Locations

Locations (1)

UC Davis Health; 🇺🇸 Sacramento, California, United States