Spots Global Cancer Trial Database for A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia

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Trial Identification

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

Official Title: A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia

Study ID: NCT05146778

Conditions

Interventions

Opioid-free anesthesia

Conventional opioid-based anesthesia

Study Description

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.

Detailed Description: Study population 1. All of patients will undergo mastectomy with or without immediate breast reconstruction. 2. 230 patients will be enrolled. Intervention 1. OFA group will be sedated using dexmedetomidine and lidocaine. 2. Conventional opioid anesthesia group will be sedated using remifentanil. Pain screening 1. Breast Cancer Pain Questionnaire (BCPQ) 2. Pain-detect, HADS, EQ-5D, PHQ-15 (somatic symptom), PCS (pain catastrophizing), BFI (big five inventory), HAM-A\&D, Pressure algometry (Pain sensitivity), Quantitative sensory test (pinprick)