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The Pectoral Block for Breast Augmentation Surgery (BPCAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040167
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Ministere de la Sante et des Services Sociaux
Information provided by (Responsible Party):
Pierre Beaulieu, Centre hospitalier de l'Université de Montréal (CHUM)

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Anesthesia; Regional Procedure: PEC 1 block Drug: Bupivacaine with epinephrine Drug: Normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study.
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : March 29, 2018

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




Primary Outcome Measures :
  1. Postoperative pain score at rest [ Time Frame: Within the first 10 min after arrival to the postanesthesia care unit (PACU) ]
    Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)


Secondary Outcome Measures :
  1. Postoperative pain score on movement [ Time Frame: Within the first 10 min after arrival to the postanesthesia care unit (PACU) ]
    Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)

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

  3. Incidence 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 ]
    Presence or absence of nausea and/or vomiting

  4. Surgical bleeding [ Time Frame: After surgery for 24 hours ]
    Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration

  5. Hematoma [ Time Frame: After surgery for 24 hours ]
    Presence or absence of hematoma at PEC 1 block injection

  6. Postoperative well-being [ Time Frame: At 24 hours after surgery ]
    Analgesic intake



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040167


Locations
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Canada, Quebec
CHUM
Montreal, Quebec, Canada, H2W 1T8
CISSS des Laurentides
Saint Jérôme, Quebec, Canada
Sponsors and Collaborators
Pierre Beaulieu
Ministere de la Sante et des Services Sociaux
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pierre Beaulieu, Professor of anesthesiology, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03040167    
Other Study ID Numbers: 17.091
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Epinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents