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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: Completed Phase 4 study of Breast Surgery, sponsored by University of California, San Diego.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes. The primary outcome measure will be the mean or median (depending on whether data is normally or not normally
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 |
What the finished NCT03860974 record still lists
NCT03860974 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03860974's enrollment target sits among peer trials
100 770th of 2000 higher than 1,149 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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