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Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05146778
Study type Interventional
Source Gangnam Severance Hospital
Contact Sung Gwe Ahn, M.D.,Ph.D.
Phone 82220194402
Status Recruiting
Phase Phase 3
Start date December 16, 2021
Completion date October 31, 2025

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