Phase 4
N=103
Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy
Pain, Postoperative · Analgesics, Opioid · Analgesics, Non-Narcotic · Physiological Effects of Drugs · Peripheral Nervous System Agents
Bottom Line
View on ClinicalTrials.gov: NCT03294109 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Change in Pain Score — 4.20; 4.62 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Abdominal wall block with liposomal bupivicaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Score |
4.20; 4.62 | — |
| SECONDARY Patient Satisfaction With Pain Management |
8.6; 9.1 | — |
| SECONDARY Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics |
9; 11; 6; 8 | — |
| SECONDARY Return of Bowel Function |
1.9; 1.9 | — |
| SECONDARY Participants Experiencing Complications Related to Surgery or Block |
5; 3 | — |
| SECONDARY Opioid Use Dose/Day |
11; 9; 6; 8; 3; 8 | — |
Summary
A blinded randomized control trial in living kidney donors. The study group will receive a liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general anesthesia. The following study variables will be collected postoperatively following arrival in the post-anesthesia care unit. Current and maximum intensity pain scores will be documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24 hours will be collected from the EHR and pain diary after discharge. Patient satisfaction will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing notes.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing laparoscopic donor nephrectomy
Exclusion Criteria
- Pregnancy
- Systemic or local infection at the potential block site.
- Allergy or hypersensitivity to the local anesthetic,
- Possible variations in surgical approach to donor nephrectomy other than what is defined in this protocol.
- Scarring or anatomic abnormality over the proposed injection site
Data sourced from ClinicalTrials.gov (NCT03294109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.