Pain, Postoperative, Anesthesia; Regional
Conditions
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.
Interventions
Treatment group
DRUGNormal saline
Placebo group
PROCEDUREPEC 1 block
Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.
Sponsors
Ministere de la Sante et des Services Sociaux
Pierre Beaulieu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| Hematoma | After surgery for 24 hours | Presence or absence of hematoma at PEC 1 block injection |
| Postoperative well-being | At 24 hours after surgery | Analgesic intake |
| Surgical bleeding | After surgery for 24 hours | Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration |
Countries
Canada
Outcome results
None listed