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Clinical Trials/NCT04382859
NCT04382859
Unknown
Not Applicable

TOTEM: Trial of TAP Block Effective Medications

Western Michigan University School of Medicine1 site in 1 country56 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Western Michigan University School of Medicine
Enrollment
56
Locations
1
Primary Endpoint
Pain rating 1 hour post operation
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
February 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Western Michigan University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Melinda Abernethy

Associate Professor

Western Michigan University School of Medicine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Known current malignancy
  • Contraindication to medications

Outcomes

Primary Outcomes

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

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

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

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

Study Sites (1)

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