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Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Université de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Etienne de Medicis, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01544959
First received: September 9, 2010
Last updated: December 29, 2013
Last verified: December 2013

September 9, 2010
December 29, 2013
January 2010
January 2014   (final data collection date for primary outcome measure)
Postoperative consumption of narcotic in recovery room [ Time Frame: Immediately after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01544959 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Postoperative Analgesia Impact of Narcotic Free Anesthesia
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pain, Postoperative
  • Breast Cancer
  • Postoperative Nausea and Vomiting
  • 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.
  • Drug: beta-blocker (esmolol, metropolol)
    esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.
  • Active Comparator: fentanyl
    Intervention: Drug: fentanyl
  • Experimental: beta-blocker
    Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control
    Intervention: Drug: beta-blocker (esmolol, metropolol)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
January 2018
January 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact: Étienne de Médicis, Dr 819-346-1110 estria1@globetrotter.net
Canada
 
NCT01544959
CRC-09-174, CAS-008-2010
No
Etienne de Medicis, Université de Sherbrooke
Université de Sherbrooke
Not Provided
Principal Investigator: Etienne de Medicis, MD MSc Centre Hospitalier Universitaire de Sherbrooke
Université de Sherbrooke
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP