Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)
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|ClinicalTrials.gov Identifier: NCT01544959|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2012
Last Update Posted : October 27, 2016
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
U.S. FDA Resources
|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.
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): 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|