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TOTEM: Trial of TAP Block Effective Medications (TOTEM)

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transversus abdominis plane (TAP) block with liposomal bupivacaine
Sponsored by
Western Michigan University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Known current malignancy
  • Contraindication to medications

Sites / Locations

  • Bronson Methodist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

TAP block with liposomal bupivacaine

TAP block with 0.25% bupivacaine

Arm Description

Active comparator

Standard comparator

Outcomes

Primary Outcome Measures

Pain rating 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
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
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
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain

Secondary Outcome Measures

Full Information

First Posted
March 1, 2020
Last Updated
November 23, 2020
Sponsor
Western Michigan University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04382859
Brief Title
TOTEM: Trial of TAP Block Effective Medications
Acronym
TOTEM
Official Title
TOTEM: Trial of TAP Block Effective Medications
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Michigan University School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAP block with liposomal bupivacaine
Arm Type
Active Comparator
Arm Description
Active comparator
Arm Title
TAP block with 0.25% bupivacaine
Arm Type
Other
Arm Description
Standard comparator
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane (TAP) block with liposomal bupivacaine
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain rating 1 hour post operation
Description
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Time Frame
1 hour post operation
Title
Pain rating 2 hours post operation
Description
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Time Frame
2 hours post operation
Title
Pain rating 4 hours post operation
Description
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Time Frame
4 hours post operation
Title
Pain rating 72 hours post operation
Description
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Time Frame
72 hours post operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melinda Abernethy, MD
Phone
(919) 260-9328
Email
melinda.abernethy@med.wmich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda Abernethy, MD
Organizational Affiliation
Western Michigan University Homer Stryker M.D. School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melinda Abernethy, MD
Phone
919-260-9328
Email
melnda.abernethy@med.wmich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

TOTEM: Trial of TAP Block Effective Medications

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