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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 room

Occurence 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

Page last updated: August 20, 2015

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