Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)

Université de Sherbrooke

Status: Completed

Conditions: Breast Cancer; Postoperative Nausea and Vomiting; Pain, Postoperative

Treatments: Drug: beta-blocker (esmolol, metropolol); Drug: fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01544959

CRC-09-174

CAS-008-2010 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

fentanyl

Active Comparator group

Treatment:

Drug: fentanyl

beta-blocker

Experimental group

Description:

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

Treatment:

Drug: beta-blocker (esmolol, metropolol)