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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: Completed Phase 4 study of Cesarean Section Complications, sponsored by Duke University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 4 |
What the finished NCT05664958 record still lists
NCT05664958 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 757-participant average among 9 other Cesarean Section Complications trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cesarean Section Complications
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05664958's enrollment target sits among peer trials
150 5th of 9 higher than 5 of 9 other Cesarean Section Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cesarean Section Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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