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NCT03860974 · ClinicalTrials.gov registry record · Phase 4
Serratus Plane 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
NCT03860974 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
NCT03860974, 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. Recently an alternative block has been reported: the serratus plane block.2 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 as there are fewer 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, therefore leakage of cerebrospinal fluid or injury to the spinal cord are less likely with the serratus compared to the PVB.3 There are, therefore, multiple theoretical reasons to prefer the serratus over the PVB. Unfortunately, it remains unknown if the analgesia provided by this new technique is comparable to that provided with the PVB.4 The investigators therefore propose to compare these two techniques with a randomized, subject-masked, active-controlled, parallel-arm clinical trial.
Conditions Studied
Interventions
- DRUG Serratus Plane block (single injection)
- DRUG Paravertebral block (single injection)
Study Locations (1)
California
- University California San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2021-02-13 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03860974
The ClinicalTrials.gov registry entry for NCT03860974 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 Serratus Plane block (single injection) is the first listed.
NCT03860974 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03860974 about?
NCT03860974 is a clinical study titled "Serratus Plane 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. Recently an alternative block...
What is the current status of trial NCT03860974?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2019-05-09. Estimated completion is 2021-02-13.
What conditions does trial NCT03860974 study?
This clinical trial studies the following conditions: Breast Surgery.
What interventions are being tested in trial NCT03860974?
The interventions under investigation include: Serratus Plane block (single injection) (DRUG), Paravertebral block (single injection) (DRUG).
Who is sponsoring clinical trial NCT03860974?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03860974 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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