TOTEM: Trial of TAP Block Effective Medications
TOTEM
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedNovember 27, 2020
November 1, 2020
Same day
March 1, 2020
November 23, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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
1 hour post operation
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
2 hours post operation
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
4 hours post operation
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
72 hours post operation
Study Arms (2)
TAP block with liposomal bupivacaine
ACTIVE COMPARATORActive comparator
TAP block with 0.25% bupivacaine
OTHERStandard comparator
Interventions
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).
Eligibility Criteria
You may qualify if:
- Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions
- English speaking
You may not qualify if:
- Known current malignancy
- Contraindication to medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melinda Abernethy, MD
Western Michigan University Homer Stryker M.D. School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 1, 2020
First Posted
May 11, 2020
Study Start
December 1, 2020
Primary Completion
December 1, 2020
Study Completion
February 1, 2021
Last Updated
November 27, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share