TOTEM: Trial of TAP Block Effective Medications

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine

• Registration Number: NCT04382859
• Lead Sponsor: Western Michigan University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-27
• Study Start: 2020-12-01
• Primary Completion: 2020-12
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

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

Exclusion Criteria

• Known current malignancy
• Contraindication to medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block with liposomal bupivacaine	Transversus abdominis plane (TAP) block with liposomal bupivacaine	Active comparator
TAP block with 0.25% bupivacaine	Transversus abdominis plane (TAP) block with liposomal bupivacaine	Standard comparator

Primary Outcome Measures

Name	Time	Method
Pain rating 1 hour post operation	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	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	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	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

Trial Locations

Locations (1)

Bronson Methodist Hospital; 🇺🇸 Kalamazoo, Michigan, United States