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Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)

This study is currently recruiting participants.
Verified February 2012 by Universitaire de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Etienne de Medicis, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01544959
First received: September 9, 2010
Last updated: March 5, 2012
Last verified: February 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Universitaire 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
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544959

Contacts
Contact: Étienne de Médicis, Dr 819-346-1110 estria1@globetrotter.net

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

No publications provided

Responsible Party: Etienne de Medicis, Doctor, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01544959     History of Changes
Other Study ID Numbers: CRC-09-174, CAS-008-2010
Study First Received: September 9, 2010
Last Updated: March 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by Universitaire de Sherbrooke:
Narcotic
Opioid
betablocking drug
postoperative pain
postoperative nausea and vomiting
breast cancer
hyperalgesia
cancer recurrence
 anesthesia
mastectomy
chronic postsurgical pain syndrome
acute postoperative pain
postmastectomy pain syndrome
pain
ambulatory surgery

Additional relevant MeSH terms:
Breast Neoplasms
Nausea
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Adrenergic beta-Antagonists
 Esmolol
Anesthetics
Fentanyl
Narcotics
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Analgesics

ClinicalTrials.gov processed this record on June 17, 2013