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Clinical trial

Subcostal TAP Block With Liposomal Bupivacaine vs Bupivacaine in Donor Nephrectomy Patients: A Prospective Randomized Study

ID
Name
1301M27261
Description
The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.
Trial arms
Trial start
2013-05-01
Estimated PCD
2014-07-01
Trial end
2014-10-01
Status
Completed
Phase
Early phase I
Treatment
liposomal bupivacaine
patients will receive a tap with liposomal bupivacaine
Arms:
liposomal bupivacaine TAP
bupivacaine
patients will receive a tap with bupivacaine
Arms:
bupivacaine TAP
Size
60
Primary endpoint
Numerical Rating Scale
48-72 hours after injection
Eligibility criteria
Inclusion Criteria: * presenting for donor nephrectomy Exclusion Criteria: * non english speaking * chronic pain condition * taking chronic opioids
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-04-10

1 organization

2 products

1 indication

Organization
University of Minnesota
Product
Liposomal Bupivacaine
Indication
Pain
Product
bupivacaine