NCT03059498

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2017

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

February 14, 2017

Last Update Submit

October 14, 2021

Conditions

Nerve Blocks

Keywords

PECS I and IIPECS blocks

Outcome Measures

Primary Outcomes (3)

  • Peak plasma bupivacaine concentration

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

    90 minutes after dose

  • Bupivacaine mean concentration

    Calculated from samples at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes

    90 Minutes after dose

  • Standard deviations of plasma bupivacaine concentrations

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

    90 minutes after dose

Secondary Outcomes (3)

  • Rates of block success

    30 minutes after block

  • Rates of adequate ultrasound success of appropriate separation of the muscular layers for each block.

    At the end of the block placement, 0 minutes timepoint.

  • Rates of symptoms of local anesthetic systemic toxicity

    90 minutes after block

Study Arms (2)

unilateral PECS block patients

ACTIVE COMPARATOR

unilateral PECS I and II block using bupivacaine

Procedure: Unilateral PECS I and II blockDrug: Bupivacaine

bilateral PECS block patients

ACTIVE COMPARATOR

bilateral PECS I and II block using bupivacaine

Procedure: Bilateral PECS I and II blockDrug: Bupivacaine

Interventions

Unilateral PECS I and II blockPROCEDURE

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

unilateral PECS block patients
Bilateral PECS I and II blockPROCEDURE

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

bilateral PECS block patients
BupivacaineDRUG

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.

bilateral PECS block patientsunilateral PECS block patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving a unilateral PECS I and II block for any surgery being provided by Wake Forest Baptist Medical Center

You may not qualify if:

  • Subjects with contraindications to regional anesthesia, such as a history of allergy to amide local anesthetics,
  • presence of a progressive neurological deficit,
  • a pre-existing coagulopathy,
  • infection at site of injection.
  • or the following conditions:
  • patient receiving any other additional local anesthetic from another procedure
  • infection over site of block
  • patient refusal
  • significant renal or liver dysfunction on laboratory analysis
  • weight \<60 kg
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Dental OcclusionBupivacaine

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • J. Douglas Jaffe, DO

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 23, 2017

Study Start

June 6, 2017

Primary Completion

November 15, 2017

Study Completion

November 15, 2017

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)