Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Etienne de Medicis, Université de Sherbrooke Identifier:
First received: September 9, 2010
Last updated: May 27, 2015
Last verified: May 2015

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.

Condition Intervention
Pain, Postoperative
Breast Cancer
Postoperative Nausea and Vomiting
Drug: fentanyl
Drug: beta-blocker (esmolol, metropolol)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy

Resource links provided by NLM:

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Postoperative consumption of narcotic in recovery room [ Time Frame: Immediately after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain level in recovery room [ Time Frame: immediately after surgery ] [ Designated as safety issue: No ]
  • Occurence of nausea and vomiting in the recovery room [ Time Frame: immediately after surgery ] [ Designated as safety issue: No ]
  • Time spent in recovery room [ Time Frame: immediately after surgery ] [ Designated as safety issue: No ]
  • Chronic post-surgical pain [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Reccurence of breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: January 2010
Estimated Study Completion Date: January 2018
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01544959

Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Principal Investigator: Etienne de Medicis, MD MSc Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Etienne de Medicis, Doctor, Université de Sherbrooke Identifier: NCT01544959     History of Changes
Other Study ID Numbers: CRC-09-174, CAS-008-2010
Study First Received: September 9, 2010
Last Updated: May 27, 2015
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
betablocking drug
postoperative pain
postoperative nausea and vomiting
breast cancer
cancer recurrence
chronic postsurgical pain syndrome
acute postoperative pain
postmastectomy pain syndrome
ambulatory surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Nausea and Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Adrenergic beta-Antagonists
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents processed this record on October 08, 2015