RecruitingNot ApplicableNCT05146778

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

A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia

Sponsor

Gangnam Severance Hospital

Enrollment

230 participants

Start Date

Dec 16, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Mastectomy Pain, Chronic Pain, Post Operative

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: FEMALEMin Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using an opioid-free anesthesia approach during mastectomy (breast removal surgery) can reduce the chance of developing long-lasting pain afterward. Persistent pain after mastectomy is a known problem, and researchers think avoiding opioids during surgery may help. **You may be eligible if...** - You are scheduled for a mastectomy, with or without immediate breast reconstruction **You may NOT be eligible if...** - You have had prior breast surgery - You have a known drug allergy - You have a history of another cancer - You have a chronic pain condition requiring pain medications - You have low blood oxygen levels (SpO2 below 95%), weak heart function (ejection fraction below 40%), very slow heart rate (below 50 bpm), or a high BMI (over 35) - You have an underlying psychological disorder - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.