Postoperative Analgesia Impact of Narcotic Free Anesthesia
Information source: Université de Sherbrooke
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative; Breast Cancer; Postoperative Nausea and Vomiting
Intervention: fentanyl (Drug); beta-blocker (esmolol, metropolol) (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Université de Sherbrooke Official(s) and/or principal investigator(s): Etienne de Medicis, MD MSc, Principal Investigator, Affiliation: Centre Hospitalier Universitaire de Sherbrooke
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.
Clinical Details
Official title: The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Postoperative consumption of narcotic in recovery room
Secondary outcome: Pain level in recovery roomOccurence of nausea and vomiting in the recovery room Time spent in recovery room Chronic post-surgical pain Reccurence of breast cancer
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
Locations and Contacts
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec J1H 5N4, Canada
Additional Information
Starting date: January 2010
Last updated: May 27, 2015
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