Postoperative Analgesia Impact of Narcotic Free Anesthesia (PAINFree)
This study is currently recruiting participants.
Verified February 2012 by Universitaire de Sherbrooke
Sponsor:
Universitaire de Sherbrooke
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
| Tracking Information | |||||
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| First Received Date ICMJE | September 9, 2010 | ||||
| Last Updated Date | March 5, 2012 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Postoperative consumption of narcotic in recovery room [ Time Frame: Immediately after surgery ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01544959 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Postoperative Analgesia Impact of Narcotic Free Anesthesia | ||||
| Official Title ICMJE | The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 84 | ||||
| Estimated Completion Date | January 2018 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01544959 | ||||
| Other Study ID Numbers ICMJE | CRC-09-174, CAS-008-2010 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Etienne de Medicis, Universitaire de Sherbrooke | ||||
| Study Sponsor ICMJE | Universitaire de Sherbrooke | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Universitaire de Sherbrooke | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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