Clinical trial · Interventional
Opioid-Free Versus Opioid-Based Anesthesia in Modified Radical Mastectomy
A Randomized Controlled Trial Comparing Opioid-Free Anesthesia With Pectoral Nerve Block and Opioid-Based Anesthesia in Patients Undergoing Modified Radical 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)
This randomized controlled trial compares opioid-free anesthesia combined with pectoral nerve block (PECS I and II) with opioid-based anesthesia in patients undergoing modified radical mastectomy. The study evaluates postoperative CD4+ T-cell counts as a marker of cellular immune response, as well as postoperative pain intensity and nausea and vomiting. Twenty-eight patients were randomly assigned to receive either opioid-free anesthesia with PECS I and II block or opioid-based anesthesia with fentanyl. CD4+ T-cell counts were assessed before and 24 hours after surgery, while postoperative pain was assessed at 2, 6, 12, and 24 hours after surgery.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexmedetomidine | Drug | — | UNRESOLVED |
| Fentanyl | Drug | — | UNRESOLVED |
| Pectoral Nerve Block (PECS I and II) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Opioid-Free Anesthesia + PECS I and II Block
- description
- Participants received opioid-free anesthesia combined with ultrasound-guided pectoral nerve blocks (PECS I and II).
- interventionNames
- Procedure: Pectoral Nerve Block (PECS I and II)
- Drug: Dexmedetomidine
- type
- ACTIVE_COMPARATOR
- label
- Opioid-Based Anesthesia
- description
- Participants received opioid-based anesthesia with fentanyl according to the study protocol.
- interventionNames
- Drug: Fentanyl
Primary outcomes (1)
- measure
- Change in Absolute CD4+ T-Cell Count From Baseline to 24 Hours After Surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged 18-65 years. 2. Patients undergoing modified radical mastectomy for breast cancer. 3. American Society of Anesthesiologists (ASA) Physical Status I-II. 4. Body mass index (BMI) \>18 and \<30 kg/m². 5. Patients who agreed to participate and provided written informed consent. Exclusion Criteria: 1. Major cardiovascular disease. 2. Cerebrovascular disease. 3. Hepatic or renal disease. 4. Uncontrolled systemic disease. 5. Previous chemotherapy or radiotherapy. 6. Long-term opioid use. 7. Allergy to local anesthetics or opioids. 8. Infection at the injection site. 9. Coagulation disorders. 10. Bilateral breast surgery. 11. Refusal to participate in the study.
References
Publications (0)
Data not yet available