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NCT03059498 · ClinicalTrials.gov registry record · Early Phase 1

PECS Block: Plasma Bupivacaine Level

A Early Phase 1 study of Nerve Blocks, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Early Phase 1
Development phase
20
Enrollment target
1
Study location

NCT03059498: Completed Early Phase 1 study of Nerve Blocks, sponsored by Wake Forest University Health Sciences.

NCT03059498 is a Early Phase 1 study of Nerve Blocks that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% 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

NCT03059498, a Early Phase 1 study of Nerve Blocks, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Early Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine peak plasma bupivacaine concentrations in a similar fashion for PECS I/II blocks. The investigators hypothesis is that the mean peak plasma levels for patients undergoing PECS I/II blocks will be less than the levels reported to cause early neurotoxicity of \[2.2 (0.9) micrograms/ml\]6 in patients receiving intravenous bupivacaine infusions.

Primary Outcome

Will be determined by samples collected at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes

Conditions Studied

Interventions

  • DRUG Bupivacaine
  • PROCEDURE Unilateral PECS I and II block
  • PROCEDURE Bilateral PECS I and II block

Study Locations (1)

North Carolina

  • Wake Forest Baptist Medical Center - Winston-Salem

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-06-06
Est. Completion 2017-11-15
Phase Early Phase 1
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT03059498 record still lists

NCT03059498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).

The record links to 1 condition, with Nerve Blocks appearing as the primary indexed condition, and to 3 interventions - of which Bupivacaine is the first listed.

NCT03059498 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT03059498 about?

NCT03059498 is a clinical study titled "PECS Block: Plasma Bupivacaine Level". The purpose of this study is to determine peak plasma bupivacaine concentrations in a similar fashion for PECS I/II blocks. The investigators hypothesis is that the mean peak plasma levels for patients undergoing PECS I/II blocks will be less than the levels reported to cause early neurotoxicity of ...

What is the current status of trial NCT03059498?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2017-06-06. Estimated completion is 2017-11-15.

What conditions does trial NCT03059498 study?

This clinical trial studies the following conditions: Nerve Blocks.

What interventions are being tested in trial NCT03059498?

The interventions under investigation include: Bupivacaine (DRUG), Unilateral PECS I and II block (PROCEDURE), Bilateral PECS I and II block (PROCEDURE).

Who is sponsoring clinical trial NCT03059498?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03059498 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03059498's enrollment target sits among peer trials

20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 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 NCT03059498, the US trial registry maintained by the National Library of Medicine. NCT03059498 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.