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

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080142
• Other study ID #: 983837
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2017
• Est. completion date: May 29, 2019

Study information

• Verified date: April 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery
• TAP Blocks

Intervention

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

Locations

Country	Name	City	State
United States	UC Davis Health	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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