A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia
Recruiting · NCT05146778 · Interventional (participants receive a specific treatment) · Lead sponsor: Gangnam Severance Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Conventional opioid-based anesthesiaOpioid-free anesthesia
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.
Who can take part
Age range
19 Years to 80 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Gangnam Severance Hospital - Seoul, South Korea