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

NCT ID: NCT03080142

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-05-29

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.

Conditions

Colorectal Surgery; TAP Blocks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Single injection of Exparel

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

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

Group 2

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: 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.

Interventions

Exparel

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

Intervention Type: DRUG

Ropivacaine

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.

Intervention Type: DRUG

Other Intervention Names

Bupivacaine liposome injectable suspension; Naropin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis Health

Locations

UC Davis Health

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

983837

Identifier Type: -

Identifier Source: org_study_id