Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)

The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Breast Cancer; Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: fentanyl; Drug: beta-blocker (esmolol, metropolol)

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fentanyl	Drug: 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.
Experimental: beta-blocker; Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control	Drug: beta-blocker (esmolol, metropolol); esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative consumption of narcotic in recovery room	Immediately after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Etienne de Medicis, MD MSc, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (Estimate): March 6, 2012

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer; anesthesia; pain; Opioid; acute postoperative pain; postoperative pain; cancer recurrence; mastectomy; postoperative nausea and vomiting; hyperalgesia; Narcotic; ambulatory surgery; betablocking drug; chronic postsurgical pain syndrome; postmastectomy pain syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Adrenergic beta-1 Receptor Antagonists; Fentanyl; Esmolol; Adrenergic beta-Antagonists
• Other Study ID Numbers: CRC-09-174; CAS-008-2010 (Other Grant/Funding Number: CAS/Vitaid Award)