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Completed

NCT Number: NCT03080142

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

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.

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Key information

Conditions

Colorectal Surgery TAP Blocks

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UC Davis Health

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Bupivacaine liposome injectable suspension

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.

Other names: Naropin

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2017
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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