Postoperative Analgesia Impact of Narcotic Free Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy

Conditions
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Pain, Postoperative, Breast Cancer, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: fentanyl
* Drug: beta-blocker (esmolol, metropolol)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fentanyl<br> | Drug: fentanyl<br>* 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.<br>|
| Experimental: beta-blocker<br>Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control | Drug: beta-blocker (esmolol, metropolol)<br>* esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative consumption of narcotic in recovery room |  | Immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Chronic post-surgical pain |  | 3 and 6 months | 
| Reccurence of breast cancer |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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