search
Back to results

The Pectoral Block for Breast Augmentation Surgery (BPCAM)

Primary Purpose

Pain, Postoperative, Anesthesia; Regional

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
PEC 1 block
Bupivacaine with epinephrine
Normal saline
Sponsored by
Pierre Beaulieu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHUM
  • CISSS des Laurentides

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

Treatment group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative pain score on movement
Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
Postoperative pain score at rest
Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
Incidence of nausea and/or vomiting
Presence or absence of nausea and/or vomiting
Surgical bleeding
Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration
Hematoma
Presence or absence of hematoma at PEC 1 block injection
Postoperative well-being
Analgesic intake

Full Information

First Posted
January 29, 2017
Last Updated
December 7, 2019
Sponsor
Pierre Beaulieu
Collaborators
Ministere de la Sante et des Services Sociaux
search

1. Study Identification

Unique Protocol Identification Number
NCT03040167
Brief Title
The Pectoral Block for Breast Augmentation Surgery
Acronym
BPCAM
Official Title
The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 12, 2018 (Actual)
Study Completion Date
March 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pierre Beaulieu
Collaborators
Ministere de la Sante et des Services Sociaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anesthesia; Regional

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance.
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
PEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance.
Intervention Type
Procedure
Intervention Name(s)
PEC 1 block
Other Intervention Name(s)
pectoral block, pecblock
Intervention Description
Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine with epinephrine
Intervention Description
Treatment group
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Placebo group
Primary Outcome Measure Information:
Title
Postoperative pain score at rest
Description
Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
Time Frame
Within the first 10 min after arrival to the postanesthesia care unit (PACU)
Secondary Outcome Measure Information:
Title
Postoperative pain score on movement
Description
Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
Time Frame
Within the first 10 min after arrival to the postanesthesia care unit (PACU)
Title
Postoperative pain score at rest
Description
Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
Time Frame
15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU
Title
Incidence of nausea and/or vomiting
Description
Presence or absence of nausea and/or vomiting
Time Frame
15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU
Title
Surgical bleeding
Description
Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration
Time Frame
After surgery for 24 hours
Title
Hematoma
Description
Presence or absence of hematoma at PEC 1 block injection
Time Frame
After surgery for 24 hours
Title
Postoperative well-being
Description
Analgesic intake
Time Frame
At 24 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
CISSS des Laurentides
City
Saint Jérôme
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29600482
Citation
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.
Results Reference
derived

Learn more about this trial

The Pectoral Block for Breast Augmentation Surgery

We'll reach out to this number within 24 hrs