Breast Cancer, Pain, Postoperative, Postoperative Nausea and Vomiting
Conditions
Keywords
Narcotic, Opioid, betablocking drug, postoperative pain, postoperative nausea and vomiting, breast cancer, hyperalgesia, cancer recurrence, anesthesia, mastectomy, chronic postsurgical pain syndrome, acute postoperative pain, postmastectomy pain syndrome, pain, ambulatory surgery
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.
Interventions
DRUGfentanyl
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.
DRUGbeta-blocker (esmolol, metropolol)
esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative consumption of narcotic in recovery room | Immediately after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Chronic post-surgical pain | 3 and 6 months |
| Pain level in recovery room | immediately after surgery |
| Occurence of nausea and vomiting in the recovery room | immediately after surgery |
| Time spent in recovery room | immediately after surgery |
| Reccurence of breast cancer | 5 years |
Countries
Canada
Outcome results
None listed