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The Pectoral Block for Breast Augmentation Surgery

NCT03040167 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-10

No results posted yet for this study

Summary

The pectoral block is a recently developed regional anesthetic technique that can be used for the treatment of postoperative pain after breast surgery. Injection of local anesthetic between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block. This block has not been well characterized in terms of its blocking effects on motor and sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical trial is divided into two sections: a volunteer study and a patient study.

For the volunteer study, the aim is to assess the sensory territory affected by injection of local anesthetics through a PEC 1 block and to assess motor function in terms of strength of adduction of the affected limb using a dynamometer.

In a prospective, randomized, controlled and double blind study, the aim is to assess the postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral breast augmentation surgery.

Conditions

  • Pain, Postoperative
  • Anesthesia; Regional

Interventions

PROCEDURE

PEC 1 block

Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.

DRUG

Bupivacaine with epinephrine

Treatment group

DRUG

Normal saline

Placebo group

Sponsors & Collaborators

  • Ministere de la Sante et des Services Sociaux

    collaborator OTHER

  • Pierre Beaulieu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-03-12
Completion
2018-03-29

Countries

  • Canada

Study Locations

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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 NCT03040167 on ClinicalTrials.gov