The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

January 31, 2023 updated by: Spectrum Health Hospitals
The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health

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:

  1. Patients over the age of 18 years w
  2. Elective laparoscopic colorectal resection.

Exclusion Criteria:

  1. Patients under 18 years.
  2. Patients unable to provide informed consent
  3. Patients undergoing emergency surgery.
  4. Pregnant women
  5. Severe liver or kidney disease (GFR 15-29 ml/min)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAP Block Experal
Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally.
Drug: Exparel
In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.
Procedure: TAP Block
no intervention will be done to this arm.
No Intervention: No TAP Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.
participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Narcotic Use
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.
participants will be followed for the duration of hospital stay, an expected average of 4 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications.
Time Frame: participants will be followed for the duration of hospital stay, and 30 days after discharge.
Any postoperative complications within 30 days of procedure, including death will be recorded.
participants will be followed for the duration of hospital stay, and 30 days after discharge.
Length of Hospital Stay.
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.
participants will be followed for the duration of hospital stay, an expected average of 4 days

Collaborators and Investigators

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

Sponsor

Spectrum Health Hospitals

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

July 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

October 13, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-066
  • DDI.FY13.07 (Other Identifier: Digestive Disease Institute/Ferguson Clinic)

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.

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