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Opioid-Free Versus Opioid-Based Anesthesia in Modified Radical Mastectomy

CompletedNA

Sponsor: Muhammad Fiqhi Amiruddin

Conditions: Breast Cancer

Interventions: Pectoral Nerve Block (PECS I and II), Dexmedetomidine, Fentanyl

Countries: Indonesia

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Makassar, South Sulawesi, Indonesia