The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.
2 other identifiers
interventional
50
1 country
1
Brief Summary
The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 postoperative-pain
Started Jul 2013
Typical duration for phase_4 postoperative-pain
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
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 2, 2013
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
February 28, 2023
CompletedFebruary 28, 2023
January 1, 2023
1.3 years
December 2, 2013
April 13, 2016
January 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative Pain Score
Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.
participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary Outcomes (1)
Postoperative Narcotic Use
participants will be followed for the duration of hospital stay, an expected average of 4 days
Other Outcomes (2)
Postoperative Complications.
participants will be followed for the duration of hospital stay, and 30 days after discharge.
Length of Hospital Stay.
participants will be followed for the duration of hospital stay, an expected average of 4 days
Study Arms (2)
TAP Block Experal
EXPERIMENTALPatient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally.
No TAP Block
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Patients over the age of 18 years w
- Elective laparoscopic colorectal resection.
You may not qualify if:
- Patients under 18 years.
- Patients unable to provide informed consent
- Patients undergoing emergency surgery.
- Pregnant women
- Severe liver or kidney disease (GFR 15-29 ml/min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spectrum Health
Grand Rapids, Michigan, 49503, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nezar Jrebi
- Organization
- Spectrum Health
Publication Agreements
- PI is Sponsor Employee
- Yes
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
December 2, 2013
First Posted
October 15, 2014
Study Start
July 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
February 28, 2023
Results First Posted
February 28, 2023
Record last verified: 2023-01