The Pectoral Block for Breast Augmentation Surgery (BPCAM)

The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anesthesia; Regional
• Intervention / Treatment: Procedure: PEC 1 block; Drug: Normal saline; Drug: Bupivacaine with epinephrine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
      • CHUM
    • Saint Jérôme, Quebec, Canada
      • CISSS des Laurentides

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance.	Procedure: PEC 1 block; Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.; Other Names: pectoral block; pecblock; Drug: Normal saline; Placebo group
Active Comparator: Treatment group; 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; Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.; Other Names: pectoral block; pecblock; Drug: Bupivacaine with epinephrine; Treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score on movement	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)
Postoperative pain score at rest	Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)	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	Presence or absence 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	Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration	After surgery for 24 hours
Hematoma	Presence or absence of hematoma at PEC 1 block injection	After surgery for 24 hours
Postoperative well-being	Analgesic intake	At 24 hours after surgery

Collaborators and Investigators

• Sponsor: Pierre Beaulieu
• Collaborators: Ministere de la Sante et des Services Sociaux

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): March 12, 2018
• Study Completion (Actual): March 29, 2018

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 7, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: 17.091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No