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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: Completed Phase 4 study of Breast Surgery, sponsored by University of California, San Diego.

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, 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.

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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.

Primary Outcome

Range scale minimum 0, maximum 10. Lower pain scores are considered a better outcome, higher pain scores are considered a worse outcome.

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

FieldValue
Enrollment Target 100 participants
Start Date 2018-07-12
Est. Completion 2019-05-08
Phase Phase 4
University of California, San Diego

775 total trials

What the finished NCT03549234 record still lists

NCT03549234 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 Erector Spinae (single injection) is the first listed.

NCT03549234 reports a single indexed study location in 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.

Similar trials for Breast Surgery

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 NCT03549234's enrollment target sits among peer trials

100 770th of 2000 higher than 1,148 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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Source: ClinicalTrials.gov NCT03549234, the US trial registry maintained by the National Library of Medicine. NCT03549234 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.