NCT05146778 A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia
| NCT ID | NCT05146778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gangnam Severance Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2021-12-16 |
| Primary Completion | 2026-07-31 |
Trial Parameters
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Brief 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 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
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