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Completed

NCT Number: NCT03040167

The Pectoral Block for Breast Augmentation Surgery

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CHUM, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEC 1 block

Procedure

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

Other names: pectoral block, pecblock

Bupivacaine with epinephrine

Drug

Treatment group

normal saline

Drug

Placebo group

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pierre Beaulieu

Other

Collaborators

  • Ministere de la Sante et des Services Sociaux

Registry information

Official study title

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

Acronym: BPCAM

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 2, 2017
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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