Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)
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.
|Pain, Postoperative Breast Cancer Postoperative Nausea and Vomiting||Drug: fentanyl Drug: beta-blocker (esmolol, metropolol)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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|
- Postoperative consumption of narcotic in recovery room [ Time Frame: Immediately after surgery ]
- Pain level in recovery room [ Time Frame: immediately after surgery ]
- Occurence of nausea and vomiting in the recovery room [ Time Frame: immediately after surgery ]
- Time spent in recovery room [ Time Frame: immediately after surgery ]
- Chronic post-surgical pain [ Time Frame: 3 and 6 months ]
- Reccurence of breast cancer [ Time Frame: 5 years ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2018|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544959
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Etienne de Medicis, MD MSc||Centre de recherche du Centre hospitalier universitaire de Sherbrooke|