MedTrace Logo

PECS Block: Plasma Bupivacaine Level

NCT03059498 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-10-15

No results posted yet for this 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.

Conditions

  • Nerve Blocks

Interventions

PROCEDURE

Unilateral PECS I and II block

A truncal block called the pectoralis nerve block (PECS I and II block). Unilateral. Using Bupivacaine

PROCEDURE

Bilateral PECS I and II block

A truncal block called the pectoralis nerve block (PECS I and II block). Bilateral. Using Bupivacaine.

DRUG

Bupivacaine

Bupivacaine solution 0.25%. At the PECS I site each patient will receive 10 cc of local anesthetic solution, and at the PECS II site an additional 20 cc of local anesthetic solution will be placed.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • J. Douglas Jaffe, DO · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2017-11-15
Completion
2017-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03059498 on ClinicalTrials.gov