Clinical trial NCT03040167: The Pectoral Block for Breast Augmentation Surgery
Official title: The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Anesthesia; Regional
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Ministere de la Sante et des Services Sociaux
First posted: 2017-02-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Postoperative pain score at rest
timeFrame: Within the first 10 min after arrival to the postanesthesia care unit (PACU)
Secondary outcomes:
measure: Postoperative pain score on movement
timeFrame: Within the first 10 min after arrival to the postanesthesia care unit (PACU)
measure: Postoperative pain score at rest
timeFrame: 15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU
measure: Incidence of nausea and/or vomiting
timeFrame: 15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU
measure: Surgical bleeding
timeFrame: After surgery for 24 hours
measure: Hematoma
timeFrame: After surgery for 24 hours
measure: Postoperative well-being
timeFrame: At 24 hours after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHUM
state: Quebec
city: Saint Jérôme
country: Canada
facility: CISSS des Laurentides
state: Quebec
Study officials:
References:
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.