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ESP Block for Post Cesarean Analgesia

NCT05664958 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-02-05

Study results available
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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.

Conditions

  • Cesarean Section Complications

Interventions

PROCEDURE

Erector Spinae Plane (ESP) Block

ESP Block with liposomal bupivacaine and immediate release bupivacaine

DRUG

bupivacaine liposome injectable suspension

133 mg liposomal bupivacaine per side.

DRUG

bupivacaine

20 ml bupivacaine 0.25% per side.

Sponsors & Collaborators

Principal Investigators

  • Ashraf S Habib, MD · Duke University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2023-11-09
Completion
2023-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664958 on ClinicalTrials.gov