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

NCT03080142 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 983837
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Surgery; TAP Blocks

Outcome Measures

Primary Outcomes (1)

• Mean Opioid Consumption in Morphine Opioid Equivalents in mg

  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

  48 hours from start of surgery

Study Arms (2)

Group 1

EXPERIMENTAL

Single injection of Exparel

Drug: Exparel

Group 2

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Interventions

Exparel DRUG

Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.

Also known as: Bupivacaine liposome injectable suspension

Group 1

Ropivacaine DRUG

Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.

Also known as: Naropin

Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Jon Zhou MD
• Organization: UC Davis Medical Center, Department of Anesthesiology

jonzhou@ucdavis.edu

9167035028

Study Officials

• Jon Zhou, MD

  UC Davis Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 15, 2017
• Study Start: March 1, 2017
• Primary Completion: May 29, 2019
• Study Completion: May 29, 2019
• Last Updated: April 27, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)