Comparing Opioid-free and Opioid-based Anesthesia to Reduce Long-term Pain After Mastectomy in Women Aged 19 to 80

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.

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