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ESP Block for Post Cesarean Analgesia
NCT05664958 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05664958
The ClinicalTrials.gov registry entry for NCT05664958 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05664958 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05664958?
This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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