Clinical trial · Interventional
Postoperative Analgesia Impact of Narcotic Free Anesthesia
The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pain, Postoperative | — | UNRESOLVED | — |
| Postoperative Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| beta-blocker (esmolol, metropolol) | Drug | — | UNRESOLVED |
| fentanyl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- fentanyl
- interventionNames
- Drug: fentanyl
- type
- EXPERIMENTAL
- label
- beta-blocker
- description
- Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control
- interventionNames
- Drug: beta-blocker (esmolol, metropolol)
Primary outcomes (1)
- measure
- Postoperative consumption of narcotic in recovery room
- timeFrame
- Immediately after surgery
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available