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

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Mastectomy, Pain, Chronic, Pain, Post Operative

In brief

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.

Key facts

Study ID

NCT05146778

Run by

Gangnam Severance Hospital

People needed

230

Starts

2021-12-16

Expected to finish

2027-10-31

Last updated by the study team

2025-11-21

Who can join

Age: 19 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All of patients will undergo mastectomy with or without immediate breast reconstruction.

You may not qualify if…

• 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

Where it is running

• Gangnam Severance Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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