Postoperative Analgesia Impact of Narcotic Free Anesthesia

NCT ID: NCT01544959

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2018-05-31

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.

Conditions

Pain, Postoperative; Breast Cancer; Postoperative Nausea and Vomiting

Study Design

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

Study Groups

fentanyl

Group Type: ACTIVE_COMPARATOR

fentanyl

Intervention Type: DRUG

Use of esmolol and metoprolol compared to use of fentanyl for hemodynamic control during general anesthesia. At induction, fentanyl (2 mcg/kg) is replaced by esmolol (1 mg/kg). During the case, with a standardised anesthesia, response to surgical stimulation will be medicated either by fentanyl (50 mcg aliquot) or metropolol (2.5 mg), for a maximum of 6 doses. After this, fentanyl will be given unblindly.

beta-blocker

Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control

Group Type: EXPERIMENTAL

beta-blocker (esmolol, metropolol)

Intervention Type: DRUG

esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.

Interventions

fentanyl

Use of esmolol and metoprolol compared to use of fentanyl for hemodynamic control during general anesthesia. At induction, fentanyl (2 mcg/kg) is replaced by esmolol (1 mg/kg). During the case, with a standardised anesthesia, response to surgical stimulation will be medicated either by fentanyl (50 mcg aliquot) or metropolol (2.5 mg), for a maximum of 6 doses. After this, fentanyl will be given unblindly.

Intervention Type: DRUG

beta-blocker (esmolol, metropolol)

esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Etienne de Medicis

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Etienne de Medicis, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

CAS-008-2010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CRC-09-174

Identifier Type: -

Identifier Source: org_study_id