The Pectoral Block for Breast Augmentation Surgery
- Conditions
- Pain, PostoperativeAnesthesia; Regional
- Interventions
- Registration Number
- NCT03040167
- Lead Sponsor
- Pierre Beaulieu
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- breast augmentation surgery
- registration at régie d'assurance maladie du Québec (RAMQ) (social services)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group PEC 1 block PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance. Control group Normal saline PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance. Treatment group PEC 1 block PEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance. Treatment group Bupivacaine with epinephrine PEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance.
- Primary Outcome Measures
Name Time Method Postoperative pain score at rest 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
Name Time Method Postoperative well-being At 24 hours after surgery Analgesic intake
Postoperative pain score on movement 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)
Postoperative pain score at rest 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)
Incidence 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 Presence or absence of nausea and/or vomiting
Surgical bleeding After surgery for 24 hours Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration
Hematoma After surgery for 24 hours Presence or absence of hematoma at PEC 1 block injection
Trial Locations
- Locations (2)
CHUM
🇨🇦Montreal, Quebec, Canada
CISSS des Laurentides
🇨🇦Saint Jérôme, Quebec, Canada