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A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia

NCT05146778 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-11-21

No results posted yet for this study

Summary

In 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (OFA) versus conventional opioid-based anesthesia in terms of chronic pain. The enrolled patients will be randomly assigned into two groups with 1:1 ratio. Chronic pain will be evaluated at 1 year after mastectomy based on the Breast Cancer Pain Questionnaire (BCPQ). Baseline pain sensitivity test and psychologic evaluation will be done before operation.

Conditions

Interventions

PROCEDURE

Opioid-free anesthesia

OFA group will be sedated using dexmedetomidine and lidocaine.

PROCEDURE

Conventional opioid-based anesthesia

Conventional opioid-based anesthesia group will be sedated using remi-fentanyl

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Principal Investigators

  • Sung Gwe G Ahn, M.D.,Ph.D. · Gangnam Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2026-07-31
Completion
2027-10-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

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 NCT05146778 on ClinicalTrials.gov