CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
bupivacaine liposome injectable suspension +2 moredrug
Likely dose
133 mg liposomal bupivacaine plus 20 mL 0.25% bupivacaine per side via erector spinae plane blockAI-extracted
Key inclusion· 4
  • Age ≥18 years
  • Term pregnancy 37–42 weeks
  • ASA Physical Status II or III
  • Scheduled for elective cesarean delivery
Key exclusion· 6
  • ≥3 prior cesarean deliveries
  • Pre-pregnancy BMI >40 kg/m²
  • Planned concurrent surgical procedure other than tubal ligation
  • Chronic pain or chronic opioid therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05664958
NCT05664958Phase 4Completed

Erector Spinae Plane Block With Liposomal Bupivacaine for Post Cesarean Delivery Analgesia: A Pilot Study

Duke University·interventional·Posted Dec 27, 2022·Updated Feb 5, 2025

In Brief

A Phase 4 clinical trial evaluating Erector Spinae Plane (ESP) Block, bupivacaine liposome injectable suspension, and 1 other intervention for Cesarean Section Complications. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedDec 27, 2022
Enrollment StartApr 17, 2023
Primary CompletionNov 9, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.5 years ago

Interventions

Erector Spinae Plane (ESP) Blockprocedure

ESP Block with liposomal bupivacaine and immediate release bupivacaine

bupivacaine liposome injectable suspensiondrug

133 mg liposomal bupivacaine per side.

bupivacainedrug

20 ml bupivacaine 0.25% per side.