This trial is active, not recruiting.

Conditions pain, postoperative, breast cancer, postoperative nausea and vomiting
Treatments fentanyl, beta-blocker (esmolol, metropolol)
Sponsor Université de Sherbrooke
Start date January 2010
End date January 2013
Trial size 84 participants
Trial identifier NCT01544959, CAS-008-2010, CRC-09-174


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
(Active Comparator)
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
beta-blocker (esmolol, metropolol)
esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.

Primary Outcomes

Postoperative consumption of narcotic in recovery room
time frame: Immediately after surgery

Secondary Outcomes

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

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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

Additional Information

Official title The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy
Principal investigator Etienne de Medicis, MD MSc
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Université de Sherbrooke.