TOTEM: Trial of TAP Block Effective Medications (TOTEM)

November 23, 2020 updated by: Melinda Abernethy, Western Michigan University School of Medicine
Our goal is to determine if liposomal bupivacaine compared to standard bupivacaine results in increased pain control and decreased narcotic pain medication use when used in TAP blocks prior to laparoscopic hysterectomies for benign indications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

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

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions
  • English speaking

Exclusion Criteria:

  • Known current malignancy
  • Contraindication to medications

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TAP block with liposomal bupivacaine
Active comparator
Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine
Transversus abdominis plane (TAP) blocks are safe and effective procedures for the provision of postoperative pain management following abdominal procedures (3) and have been widely used across specialties with reduction in postoperative pain and narcotic use (4-7).
OTHER: TAP block with 0.25% bupivacaine
Standard comparator
Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine
Transversus abdominis plane (TAP) blocks are safe and effective procedures for the provision of postoperative pain management following abdominal procedures (3) and have been widely used across specialties with reduction in postoperative pain and narcotic use (4-7).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain rating 1 hour post operation
Time Frame: 1 hour post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
1 hour post operation
Pain rating 2 hours post operation
Time Frame: 2 hours post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
2 hours post operation
Pain rating 4 hours post operation
Time Frame: 4 hours post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
4 hours post operation
Pain rating 72 hours post operation
Time Frame: 72 hours post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
72 hours post operation

Collaborators and Investigators

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

Sponsor

Western Michigan University School of Medicine

Investigators

  • Principal Investigator: Melinda Abernethy, MD, Western Michigan University Homer Stryker M.D. School of Medicine

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 (ANTICIPATED)

December 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

March 1, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (ACTUAL)

May 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMed-2020-0601

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

No

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.

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