Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2017
CompletedMarch 20, 2019
March 1, 2019
1.5 years
April 13, 2016
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraoperative remifentanil consumption for the first 30 minutes of surgery
30 minutes
Secondary Outcomes (6)
Total intraoperative remifentanil consumption
2 hours
Total intraoperative sevoflurane consumption
2 hours
Postoperative pain evaluation
30 minutes
Postoperative nausea and vomiting evaluation
30 minutes
Total time in the recovery room
60 minutes
- +1 more secondary outcomes
Study Arms (2)
Pectoral nerve block
ACTIVE COMPARATORAfter 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.
Sham block
SHAM COMPARATORNo needle or injection will be used
Interventions
Eligibility Criteria
You may qualify if:
- ASA 1 to 3 inclusively
- breast cancer surgery with or without axillary dissection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
April 13, 2016
First Posted
April 18, 2016
Study Start
March 1, 2016
Primary Completion
August 30, 2017
Study Completion
September 15, 2017
Last Updated
March 20, 2019
Record last verified: 2019-03