Reducing post-mastectomy pain with opioid-free anesthesia
A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia
This study is testing whether using anesthesia without opioids can help women who have had a mastectomy experience less chronic pain a year after their surgery compared to traditional opioid-based anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | Female |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05146778 on ClinicalTrials.gov |
What this trial studies
This study involves 230 patients undergoing mastectomy, where participants will be randomly assigned to receive either opioid-free anesthesia or conventional opioid-based anesthesia. The aim is to compare the effectiveness of these two approaches in reducing chronic pain one year after surgery. Pain assessments will be conducted using various questionnaires and tests to evaluate pain sensitivity and psychological factors before and after the procedure.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for mastectomy with or without immediate breast reconstruction.
Not a fit: Patients with a history of breast surgery, chronic pain requiring painkillers, or underlying psychological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of chronic pain following mastectomy without the use of opioids.
How similar studies have performed: Other studies have shown promising results with opioid-free anesthesia in various surgical settings, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Gangnam Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Sung Gwe G Ahn, M.D.,Ph.D. — Gangnam Severance Hospital
- Study coordinator: Sung Gwe Ahn, M.D.,Ph.D.
- Email: asg2004@yuhs.ac
- Phone: 82220194402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.