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NCT05664958 · ClinicalTrials.gov registry record · Phase 4

ESP Block for Post Cesarean Analgesia

A Phase 4 study of Cesarean Section Complications, sponsored by Duke University.

Completed
Registry status
Phase 4
Development phase
150
Enrollment target
1
Study location

NCT05664958 is a Phase 4 study of Cesarean Section Complications that has completed, run by Duke University. The registered enrollment target is 150 participants, below the 757-participant average among 9 other Cesarean Section Complications trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05664958, a Phase 4 study of Cesarean Section Complications, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 4
Development phase
150 participants
Enrollment target
1
Study location

Study 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 Studied

Cesarean Section Complications

Interventions

  • DRUG bupivacaine
  • PROCEDURE Erector Spinae Plane (ESP) Block
  • DRUG bupivacaine liposome injectable suspension

Study Locations (1)

North Carolina

  • Duke University Hospital - Durham

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2023-04-17
Est. Completion 2023-11-09
Phase Phase 4

Sponsor

Duke University

1,725 total trials

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What the Registry Record Tells You About NCT05664958

The ClinicalTrials.gov registry entry for NCT05664958 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 757-participant average among 9 other Cesarean Section Complications trials with a reported enrollment target (80% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cesarean Section Complications appearing as the primary indexed condition, and to 3 interventions - of which bupivacaine is the first listed.

NCT05664958 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT05664958 about?

NCT05664958 is a clinical study titled "ESP Block for Post Cesarean Analgesia". 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 h...

What is the current status of trial NCT05664958?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2023-04-17. Estimated completion is 2023-11-09.

What conditions does trial NCT05664958 study?

This clinical trial studies the following conditions: Cesarean Section Complications.

What interventions are being tested in trial NCT05664958?

The interventions under investigation include: bupivacaine (DRUG), Erector Spinae Plane (ESP) Block (PROCEDURE), bupivacaine liposome injectable suspension (DRUG).

Who is sponsoring clinical trial NCT05664958?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05664958 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.