Actively Recruiting
A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia
Led by Gangnam Severance Hospital · Updated on 2025-11-21
230
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled to undergo mastectomy with or without immediate breast reconstruction
You will not qualify if you...
- Previous history of breast surgery
- Allergy to study drugs
- History of other cancers
- Underlying psychological disorders
- Chronic pain requiring painkillers
- Baseline oxygen saturation (SpO2) below 95%
- Left ventricular ejection fraction below 40%
- Bradycardia with heart rate below 50 bpm
- Body mass index over 35 kg/m2
- Pregnant women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gangnam Severance Hospital
Seoul, South Korea, 135270
Actively Recruiting
Research Team
S
Sung Gwe Ahn, M.D.,Ph.D.
CONTACT
S
Soong June Bae, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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