Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01544959
Recruitment Status : Active, not recruiting
First Posted : March 6, 2012
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
Etienne de Medicis, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Breast Cancer Postoperative Nausea and Vomiting Drug: fentanyl Drug: beta-blocker (esmolol, metropolol) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Estimated Study Completion Date : January 2018

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.

Primary Outcome Measures :
  1. Postoperative consumption of narcotic in recovery room [ Time Frame: Immediately after surgery ]

Secondary Outcome Measures :
  1. Pain level in recovery room [ Time Frame: immediately after surgery ]
  2. Occurence of nausea and vomiting in the recovery room [ Time Frame: immediately after surgery ]
  3. Time spent in recovery room [ Time Frame: immediately after surgery ]
  4. Chronic post-surgical pain [ Time Frame: 3 and 6 months ]
  5. Reccurence of breast cancer [ Time Frame: 5 years ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 de recherche du Centre hospitalier universitaire de Sherbrooke

Responsible Party: Etienne de Medicis, Doctor, Université de Sherbrooke Identifier: NCT01544959     History of Changes
Other Study ID Numbers: CRC-09-174
CAS-008-2010 ( Other Grant/Funding Number: CAS/Vitaid Award )
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by Etienne de Medicis, 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
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Adrenergic beta-Antagonists
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-1 Receptor Antagonists