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Clinical trial

The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

ID
Name
2013-066
Description
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 arms
Trial start
2013-07-01
Estimated PCD
2014-11-01
Trial end
2014-11-01
Status
Completed
Phase
Early phase I
Treatment
Exparel
In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.
Arms:
TAP Block Experal
TAP Block
no intervention will be done to this arm.
Arms:
TAP Block Experal
Size
50
Primary endpoint
Postoperative Pain Score
participants will be followed for the duration of hospital stay, an expected average of 4 days
Eligibility criteria
Inclusion Criteria: 1. Patients over the age of 18 years w 2. Elective laparoscopic colorectal resection. Exclusion Criteria: 1. Patients under 18 years. 2. Patients unable to provide informed consent 3. Patients undergoing emergency surgery. 4. Pregnant women 5. Severe liver or kidney disease (GFR 15-29 ml/min)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-02-28

1 organization

1 product

1 indication

Organization
Spectrum Health Hospitals
Product
Exparel
Indication
Postoperative Pain