Postoperative Analgesia Impact of Narcotic Free Anesthesia

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting; Breast Cancer; Pain, Postoperative
• Interventions: Drug: beta-blocker (esmolol, metropolol); Drug: fentanyl

• Registration Number: NCT01544959
• Lead Sponsor: Université de Sherbrooke

Brief Summary

The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol during general anesthesia for patients undergoing mastectomy will result in less pain and less narcotic consumption in the recovery room. The investigators will also verify the impact of that substitution on nausea and vomiting, on the time spent in the recovery room and on chronic postsurgical pain (3 and 6 months).

Finally, the investigators will see the impact on breast cancer recurrence 5 years after the surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Primary Completion: 2013-01
• Study Completion: 2018-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Woman
• 18 to 65 years old
• ASA 1 or 2
• First breast surgery
• Unilateral breast cancer
• Partial mastectomy or radical modified mastectomy ± axillary dissection

Exclusion Criteria

• Allergy or contrindication to any medication figuring in the protocol or to Aspirin
• Patient taking betablocking drug drug or lanoxin or calcic channels blocking drug
• Narcotic consumption in the past month of 10 mg/day of morphine equivalent
• Chronic pain
• Moderate to severe asthma
• BMI of more than 40
• Diabetes
• Chronic renal or hepatic faiure
• Heart failure
• Anticipated difficult airway
• High grade heart block or bifascicular block
• Mental retardation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
beta-blocker	beta-blocker (esmolol, metropolol)	Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control
fentanyl	fentanyl	-

Primary Outcome Measures

Name	Time	Method
Postoperative consumption of narcotic in recovery room	Immediately after surgery

Secondary Outcome Measures

Name	Time	Method
Pain level in recovery room	immediately after surgery
Occurence of nausea and vomiting in the recovery room	immediately after surgery
Chronic post-surgical pain	3 and 6 months
Reccurence of breast cancer	5 years
Time spent in recovery room	immediately after surgery

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada