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Clinical Trials in South Korea / NCT05146778
Recruiting Not applicable

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

NCT05146778 · tracked via the Priya Life Science South Korea tracker
Sponsor
Gangnam Severance Hospital
Phase
Not applicable
Started
2021-12-16
Last updated
2025-11-21

Condition(s) studied

Breast CancerMastectomyPain, ChronicPain, Post Operative

Investigational drug(s) / intervention(s)

Opioid-free anesthesiaConventional opioid-based anesthesia

Opioid-free anesthesia: OFA group will be sedated using dexmedetomidine and lidocaine.

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

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.

Eligibility

Sex
FEMALE
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * All of patients will undergo mastectomy with or without immediate breast reconstruction. Exclusion Criteria: * Previous history of breast surgery * Allergy to drug * Other cancer history * Underlying psychologic disorder * Patients with chronic pain requiring pain killers * Baseline SpO2 \<95% * Left ventricular EF \<40% * Bradycardia as HR \<50 bpm * BMI \>35kg/m2 * Pregnant woman

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Gangnam Severance Hospital Seoul South Korea Recruiting

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Other trials for the same condition

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OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05146778 on ClinicalTrials.gov ↗ ← All trials in South Korea