drugset / Trial / NCT05664958

ESP Block for Post Cesarean Analgesia

NCT05664958 ↗

Phase 4 Completed 150 enrolled Duke University
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this pilot study is to assess the analgesic efficacy of Erector Spinae Plane block (ESPB) with liposomal bupivacaine in women undergoing cesarean delivery and receiving a postoperative multimodal analgesic regimen as assessed by the dose of rescue postoperative opioids compared to a historical control group of women receiving the same multimodal regimen but with no truncal blocks. This will be a case control study with a prospective and a retrospective component. Women undergoing elective cesarean delivery under spinal or combined spinal epidural anesthesia will be approached to participate in the prospective open label component of the study. Cases will be matched in a 1:4 ratio by age, race, history of prior cesarean delivery, and insurance status with historical controls who received the same multimodal analgesic regimen but no truncal blocks. We plan to enroll 30 subjects for the prospective arm of the study and 120 for the retrospective arm.

Timeline

Start
2023-04-17
Primary completion
2023-11-09
Completion
2023-11-09

Outcome

Missed primary endpoint

paper There were no significant differences between the groups in 48-h oxycodone consumption (median, 12.5 [interquartile range (IQR), 5.0-40.0] vs. PMID 39981694 ↗

paper ESPB with liposomal bupivacaine did not reduce postoperative opioid consumption PMID 39981694 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 20 ml Other
Subject Bupivacaine Other / unclassified 133 mg Other

Indications

No indication recorded.