Clinical trial NCT02741232: Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery
Official title: Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block Under General Anesthesia for Breast Cancer Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Mastectomy
Keywords: analgesics, opioids
pectoral block
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators will compare the intraoperative opioid consumption for patients undergoing breast cancer surgery. The patients will be divided in two groups, the first one will receive a pectoral nerve block right after induction of anesthesia and the second one, the control group, will not receive the pectoral block. Our hypothesis is that the pectoral nerve block reduces the opioid consumption during the surgery.

Detailed description: After induction of general anesthesia with propofol, remifentanil and succinylcholine, the patients will be divided either in the pectoral block group or the control group (sham block). Both groups will receive the same perioperative and postoperative anesthetic protocol. The investigator in charge of the patient will leave the operative room right before the completion of the pectoral block (or the sham block) to preserve randomisation and the block will be performed by another investigator. The pectoral block is performed under ultrasound guidance with 10 cc of lidocaine 1% with epinephrine 1/400000 between the pectoralis major muscle and the pectoralis minor muscle and 20 cc of the same solution between the pectoralis minor muscle and the serratus anterior muscle at the third rib. Anesthesia will be maintained with sevoflurane for a bispectral (BIS) index between 45 and 60. Analgesia will be provided with a perfusion of remifentanil adjusted to maintain a mean arterial blood pressure (MAP) in the range of ± 10% of the basal MAP (mean of the last three MAPs obtained before surgical incision, under sevoflurane-only anesthesia). The total remifentanil consumption will be assessed and compared between the groups. The investigators believe that the pectoral nerve block will significantly reduce the intraoperative remifentanil consumption.

Eligibility criteria: Inclusion Criteria:

* ASA 1 to 3 inclusively
* breast cancer surgery with or without axillary dissection

Exclusion Criteria:

* any contraindication to the pectoral nerve block (coagulopathy, infection, pre- existing neuropathy, local anesthetic allergy and refusal of local anesthesia)
* refusal to participate in the study
* patient with dementia
* preoperative breast pain
* preoperative opioid consumption
* breast reconstructive surgery
* bilateral surgery
* pregnant patient

Primary outcomes:
measure: Intraoperative remifentanil consumption for the first 30 minutes of surgery
timeFrame: 30 minutes
Secondary outcomes:
measure: Total intraoperative remifentanil consumption
timeFrame: 2 hours
measure: Total intraoperative sevoflurane consumption
timeFrame: 2 hours
measure: Postoperative pain evaluation
timeFrame: 30 minutes
measure: Postoperative nausea and vomiting evaluation
timeFrame: 30 minutes
measure: Total time in the recovery room
timeFrame: 60 minutes
measure: Postoperative opioid consumption
timeFrame: 1 hour
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
References: