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The Pectoral Block for Breast Augmentation Surgery

NCT ID: NCT03040167

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-03-29

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative Anesthesia; Regional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance.

Group Type PLACEBO_COMPARATOR

PEC 1 block

Intervention Type PROCEDURE

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

Normal saline

Intervention Type DRUG

Placebo group

Treatment group

PEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance.

Group Type ACTIVE_COMPARATOR

PEC 1 block

Intervention Type PROCEDURE

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

Bupivacaine with epinephrine

Intervention Type DRUG

Treatment group

Interventions

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PEC 1 block

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

Intervention Type PROCEDURE

Bupivacaine with epinephrine

Treatment group

Intervention Type DRUG

Normal saline

Placebo group

Intervention Type DRUG

Other Intervention Names

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pectoral block pecblock

Eligibility Criteria

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Inclusion Criteria

* breast augmentation surgery
* registration at régie d'assurance maladie du Québec (RAMQ) (social services)

Exclusion Criteria

* known bleeding disorder
* anticoagulant intake
* infection at site of PEC 1 block
* pregnant or breast-feeding women
* allergy to bupivacaine
* chronic pain including fibromyalgia with regular analgesic consumption
* under recreational drugs or alcohol at doses above canadian recommendations
* muscle relaxants intake
* patients already operated for breast augmentation or mastectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministere de la Sante et des Services Sociaux

OTHER

Sponsor Role collaborator

Pierre Beaulieu

OTHER

Sponsor Role lead

Responsible Party

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Pierre Beaulieu

Professor of anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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CHUM

Montreal, Quebec, Canada

Site Status

CISSS des Laurentides

Saint-Jérôme, Quebec, Canada

Site Status

Countries

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Canada

References

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Desroches J, Belliveau M, Bilodeau C, Landry M, Roy M, Beaulieu P. Pectoral nerves I block is associated with a significant motor blockade with no dermatomal sensory changes: a prospective volunteer randomized-controlled double-blind study. Can J Anaesth. 2018 Jul;65(7):806-812. doi: 10.1007/s12630-018-1122-2. Epub 2018 Mar 29.

Reference Type DERIVED
PMID: 29600482 (View on PubMed)

Other Identifiers

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17.091

Identifier Type: -

Identifier Source: org_study_id