Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery

NCT ID: NCT02741232

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-09-15

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.

Conditions

Nerve Block; Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pectoral nerve block

After induction of general anesthesia and under ultrasound visual guidance, pectoral block is performed with 30 mL total of local anesthetic (1% lidocaine + 1/400000 epinephrine). 10 mL of local anesthetic between pectoralis major muscle and pectoralis minor muscle and 20 mL between pectoralis minor muscle and serratus anterior muscle at the third rib.

Group Type: ACTIVE_COMPARATOR

Lidocaine 1% with epinephrine 1/400000

Intervention Type: DRUG

Sham block

No needle or injection will be used

Group Type: SHAM_COMPARATOR

sham block

Intervention Type: OTHER

Interventions

Lidocaine 1% with epinephrine 1/400000

Intervention Type: DRUG

sham block

Intervention Type: OTHER

Other Intervention Names

xylocaine with epinephrine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olivier Verdonck

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

15075

Identifier Type: -

Identifier Source: org_study_id