Back to resultsTOTEM: 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
About this trial
This is an interventional prevention trial for Pain, Postoperative
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
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
NCT ID
NCT04382859
First Posted
March 1, 2020
Last Updated
November 23, 2020
Sponsor
Western Michigan University School of Medicine
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
We'll reach out to this number within 24 hrs