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

NCT07798895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-09-02

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Pectoral Nerve Block (PECS I and II)

Ultrasound-guided pectoral nerve blocks (PECS I and II) performed before induction of general anesthesia.

DRUG

Dexmedetomidine

Dexmedetomidine-based opioid-free anesthetic regimen administered according to the study protocol.

DRUG

Fentanyl

Fentanyl-based opioid anesthesia administered according to the study protocol.

Sponsors & Collaborators

  • Muhammad Fiqhi Amiruddin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-03
Primary Completion
2026-07-27
Completion
2026-07-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07798895 on ClinicalTrials.gov