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

Breast Cancer Clinical Trial

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

Status Recruiting

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) ;

Related Conditions & MeSH terms

• Breast Cancer
• Chronic Pain
• Mastectomy
• Pain, Chronic
• Pain, Post Operative
• Pain, Postoperative

• NCT number: NCT05146778
• Study type: Interventional
• Source: Gangnam Severance Hospital
• Contact: Sung Gwe Ahn, M.D.,Ph.D.
• Phone: 82220194402
• Email: asg2004@yuhs.ac
• Status: Recruiting
• Phase: Phase 3
• Start date: December 16, 2021
• Completion date: October 31, 2025