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

NCT07798895 | Completed

• 1 other identifier: OFA-PECS-MRM-2026
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

opioid-free anesthesia; opioid-based anesthesia; pectoral nerve block; PECS block; modified radical mastectomy; CD4+ T-cell; postoperative pain; postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• Change in Absolute CD4+ T-Cell Count From Baseline to 24 Hours After Surgery

  Change in absolute CD4+ T-cell count measured from baseline before surgery to 24 hours after surgery. CD4+ T-cell counts were measured using the Pima™ Alere CD4 Analyzer.

  Baseline to 24 hours after surgery

Secondary Outcomes (2)

• Postoperative Pain Intensity

  2, 6, 12, and 24 hours after surgery

• Postoperative Nausea and Vomiting

  Within 24 hours after surgery

Study Arms (2)

Opioid-Free Anesthesia + PECS I and II Block

EXPERIMENTAL

Participants received opioid-free anesthesia combined with ultrasound-guided pectoral nerve blocks (PECS I and II).

Procedure: Pectoral Nerve Block (PECS I and II); Drug: Dexmedetomidine

Opioid-Based Anesthesia

ACTIVE COMPARATOR

Participants received opioid-based anesthesia with fentanyl according to the study protocol.

Drug: Fentanyl

Interventions

Dexmedetomidine DRUG

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

Opioid-Free Anesthesia + PECS I and II Block

Fentanyl DRUG

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

Opioid-Based Anesthesia

Pectoral Nerve Block (PECS I and II) PROCEDURE

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

Opioid-Free Anesthesia + PECS I and II Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-65 years.
• Patients undergoing modified radical mastectomy for breast cancer.
• American Society of Anesthesiologists (ASA) Physical Status I-II.
• Body mass index (BMI) \>18 and \<30 kg/m².
• Patients who agreed to participate and provided written informed consent.

You may not qualify if:

• Major cardiovascular disease.
• Cerebrovascular disease.
• Hepatic or renal disease.
• Uncontrolled systemic disease.
• Previous chemotherapy or radiotherapy.
• Long-term opioid use.
• Allergy to local anesthetics or opioids.
• Infection at the injection site.
• Coagulation disorders.
• Bilateral breast surgery.
• Refusal to participate in the study.

Sponsors & Collaborators

• Muhammad Fiqhi Amiruddin: lead

Study Sites (1)

Jl. Perintis Kemerdekaan Km. 10, Makassar 90245, Indonesia

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Participants were randomly assigned in a 1:1 ratio to receive either opioid-free anesthesia combined with PECS I and II block or opioid-based anesthesia. Each participant received the assigned intervention throughout the perioperative period.

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: May 3, 2026
• Primary Completion: July 27, 2026
• Study Completion: July 30, 2026
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)