Actively Recruiting
A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia
Led by Gangnam Severance Hospital · Updated on 2025-11-21
230
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating opioid-free anesthesia (OFA) compared to conventional opioid-based anesthesia to reduce chronic pain after mastectomy in women. The study will enroll 230 patients undergoing mastectomy with or without immediate breast reconstruction. The goal is to assess chronic breast pain one year after surgery using the Breast Cancer Pain Questionnaire (BCPQ), along with psychological and pain sensitivity evaluations. Participants will be randomly assigned to one of two groups. One group will receive opioid-free anesthesia with dexmedetomidine and lidocaine during mastectomy, while the other group will receive conventional opioid-based anesthesia using remifentanil. Both treatments are delivered during the surgical procedure. Participants will be assessed before surgery with pain sensitivity tests and psychological evaluations. After surgery, chronic pain, psychological symptoms, and pain sensitivity will be measured at one year. Researchers will use questionnaires such as BCPQ, Pain-detect, HADS, EQ-5D, and others to monitor outcomes. The total duration of participation is one year following mastectomy, with ongoing monitoring of pain and psychological health.
CONDITIONS
Brief 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 pain medication
- Baseline oxygen saturation 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo mastectomy with or without immediate breast reconstruction and receive anesthesia as assigned: either opioid-free anesthesia with dexmedetomidine and lidocaine or conventional opioid-based anesthesia with remifentanil.
1 visit (in-person)
Duration - Up to 1 year after mastectomy
Participants are monitored for recovery after surgery and anesthesia. Pain sensitivity and psychological symptoms assessments are conducted.
Follow-up visits as scheduled up to 1 year
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.
S
Soong June Bae, M.D.
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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