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NCT03549234 · ClinicalTrials.gov registry record · Phase 4
Erector Spinae Versus Paravertebral Nerve Blocks for Breast Surgery
A Phase 4 study of Breast Surgery, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT03549234 is a Phase 4 study of Breast Surgery that has completed, run by University of California, San Diego. The registered enrollment target is 100 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03549234, a Phase 4 study of Breast Surgery, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Following painful surgical procedures of the breast, postoperative analgesia is often provided with a paravertebral nerve block (PVB). For intense, but shorter-duration acute pain, a single-injection of local anesthetic is used with a duration of approximately 12 hours. The PVB has several limitations: it can decrease blood pressure, and very rare-but serious-complications have occurred, including neuraxial injection, neuraxial hematoma, and pleural puncture. An alternative block has been described: the erector spinae plane block. The theoretical benefits include ease of administration since it is a plane superficial to the PVB and therefore easier to identify and target with ultrasound (therefore increasing success rate); and an increased safety margin: there are few anatomic structures in the immediate area which could be injured with the needle; and, the target plane is much further from the intrathecal/epidural space relative to the PVB. Lastly, the plane may be easier to catheterize for continuous peripheral nerve blocks relative to the relatively-small volume PVB. There are therefore multiple theoretical reasons to prefer the erector spinae plane block. Unfortunately, it remains unknown if the analgesia provided by this new technique is comparable to that provided with the PVB. The investigators therefore propose to compare these two techniques with a randomized, subject-masked, active-controlled, parallel-arm, human subjects clinical trial.
Conditions Studied
Interventions
- DRUG Erector Spinae (single injection)
- DRUG Paravertebral (single injection)
Study Locations (1)
California
- UCSD Medical Center (Hillcrest and Thornton) - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-07-12 |
| Est. Completion | 2019-05-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03549234
The ClinicalTrials.gov registry entry for NCT03549234 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Surgery appearing as the primary indexed condition, and to 2 interventions - of which Erector Spinae (single injection) is the first listed.
NCT03549234 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03549234 about?
NCT03549234 is a clinical study titled "Erector Spinae Versus Paravertebral Nerve Blocks for Breast Surgery". Following painful surgical procedures of the breast, postoperative analgesia is often provided with a paravertebral nerve block (PVB). For intense, but shorter-duration acute pain, a single-injection of local anesthetic is used with a duration of approximately 12 hours. The PVB has several limitatio...
What is the current status of trial NCT03549234?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2018-07-12. Estimated completion is 2019-05-08.
What conditions does trial NCT03549234 study?
This clinical trial studies the following conditions: Breast Surgery.
What interventions are being tested in trial NCT03549234?
The interventions under investigation include: Erector Spinae (single injection) (DRUG), Paravertebral (single injection) (DRUG).
Who is sponsoring clinical trial NCT03549234?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03549234 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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