The Pectoral Block for Breast Augmentation Surgery

NCT03040167 | Completed Phase 4 DMC

• 1 other identifier: 17.091
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score at rest

  Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)

  Within the first 10 min after arrival to the postanesthesia care unit (PACU)

Secondary Outcomes (6)

• Postoperative pain score on movement

  Within the first 10 min after arrival to the postanesthesia care unit (PACU)

• Postoperative pain score at rest

  15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU

• Incidence of nausea and/or vomiting

  15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU

• Surgical bleeding

  After surgery for 24 hours

• Hematoma

  After surgery for 24 hours

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Procedure: PEC 1 block; Drug: Normal saline

Treatment group

ACTIVE COMPARATOR

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

Procedure: PEC 1 block; Drug: Bupivacaine with epinephrine

Interventions

PEC 1 block PROCEDURE

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

Also known as: pectoral block, pecblock

Control group; Treatment group

Bupivacaine with epinephrine DRUG

Treatment group

Treatment group

Normal saline DRUG

Placebo group

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Beaulieu: lead
• Ministere de la Sante et des Services Sociaux: collaborator

Study Sites (2)

CHUM

Montreal, Quebec, H2W 1T8, Canada

Location

CISSS des Laurentides

Saint-Jérôme, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 29600482 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of anesthesiology

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: February 2, 2017
• Study Start: October 1, 2017
• Primary Completion: March 12, 2018
• Study Completion: March 29, 2018
• Last Updated: December 10, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)