Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery
TAP (Transverse Abdominis Plane) Block With Exparel (Liposomal Bupivicaine) vs. Bupivicaine Post-op Pain Management
1 other identifier
interventional
76
1 country
1
Brief Summary
Single Blind, Randomized Controlled study to see if TAP Block with Exparel provides better pain relief than TAP Block with bupivicaine. Differences in Pain Scale, Length of Stay, and Total Narcotic use in the hospital will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2017
Longer than P75 for phase_4
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
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedSeptember 10, 2021
September 1, 2021
3.1 years
April 11, 2019
September 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pain Scale
Daily Pain Scale using Wong-baker FACES Pain Rating Scale 0 (no pain) - 10 (worst pain imaginable)
daily through study completion (up to 30 days)
Secondary Outcomes (2)
Length of stay
daily through study completion (up to 30 days)
Narcotic use
daily through study completion (up to 30 days)
Study Arms (2)
TAP Block with Exparel
EXPERIMENTALTAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline
TAP Block with bupivicaine
ACTIVE COMPARATORTAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline
Interventions
Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days)
Given at the beginning of the surgery for post-operative pain management
Given at the beginning of the surgery for post-operative pain management
Eligibility Criteria
You may qualify if:
- Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection
You may not qualify if:
- Patients younger than 18 or older than 75 years old
- Pregnant women
- Patients who have taken steroids or other immunomodulators within the last 6 months
- Patients on home narcotics
- Patients allergic to Exparel or bupivacaine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Related Publications (1)
Chevrollier GS, Klinger AL, Green HJ, Gastanaduy MM, Johnston WF, Vargas HD, Kann BR, Whitlow CB, Paruch JL. Liposomal Bupivacaine Transversus Abdominis Plane Blocks in Laparoscopic Colorectal Resections: A Single-Institution Randomized Controlled Trial. Dis Colon Rectum. 2023 Feb 1;66(2):322-330. doi: 10.1097/DCR.0000000000002346. Epub 2022 May 24.
PMID: 35849756DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Whitlow, MD
Ochsner
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2019
First Posted
March 4, 2021
Study Start
December 1, 2017
Primary Completion
December 31, 2020
Study Completion
July 31, 2021
Last Updated
September 10, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share