Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

August 14, 2019 updated by: Inova Health Care Services

TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial

The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects.

Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively).

In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Fairfax Colon & Rectal Surgery, Alexandria Office
      • Fairfax, Virginia, United States, 22031
        • Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office
      • Fairfax, Virginia, United States, 22033
        • Fairfax Colon & Rectal Surgery, Fair Oaks Office
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
      • Lansdowne Town Center, Virginia, United States, 20176
        • Fairfax Colon & Rectal Surgery, Loudoun Office
      • Reston, Virginia, United States, 20190
        • Fairfax Colon & Rectal Surgery, Reston Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery

Exclusion Criteria:

  • Allergic to local anesthetics
  • Unable to provide consent
  • Pregnant
  • On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study)
  • Undergoing emergent operations
  • Undergoing loop ileostomy reversal
  • Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Bupivacaine
Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
Drug: Bupivacaine
Abdominal injection of bupivacaine into fascial layer.
Other Names:
  • Marcaine
EXPERIMENTAL: Bupivacaine Liposome
Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
Drug: Bupivacaine liposome
Abdominal injection of bupivacaine liposome into fascial layer.
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital Postoperative Opioid Consumption
Time Frame: up to postoperative day 3 at 1 pm
Daily overall opioid use recorded as morphine equivalents
up to postoperative day 3 at 1 pm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: Approximately every 6 hours through postoperative day 3 by 1 pm
Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)
Approximately every 6 hours through postoperative day 3 by 1 pm
Time to Patient Mobilization
Time Frame: From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).
Number of days from day of surgery until patient mobilization
From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).
Time to Return of Bowel Function
Time Frame: From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).
Number of days from time of surgery until return of bowel function
From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).
Time to Clear Liquid Diet
Time Frame: From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).
Number of days from time of surgery until patient tolerates clear liquid diet
From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).
Time to Low Fiber Diet
Time Frame: From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).
Number of days from day of surgery until patient tolerates low fiber diet
From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).
Length of Stay
Time Frame: Date of surgery to date of discharge (usually up to 4 days after surgery).
Total postoperative hospital stay in days
Date of surgery to date of discharge (usually up to 4 days after surgery).
In-hospital Antiemetic Use
Time Frame: Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).
Amount of ondansetron patient required postoperatively during hospital stay, in milligrams
Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).
Complications
Time Frame: Within 30 days of surgery
Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery
Within 30 days of surgery
Readmissions
Time Frame: Within 30 days of hospital discharge
Patient readmitted to hospital after discharge
Within 30 days of hospital discharge
Mortality
Time Frame: Within 30 days of surgery
Patient death after surgery
Within 30 days of surgery
Hospitalization Costs
Time Frame: From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).
Total hospitalization costs per patient per this surgical encounter
From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Donald Colvin, MD, Inova Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2018

Primary Completion (ACTUAL)

January 16, 2019

Study Completion (ACTUAL)

January 16, 2019

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 17, 2018

First Posted (ACTUAL)

August 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on Bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe