NCT05146778

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Opioid-free anesthesia	OFA group will be sedated using dexmedetomidine and lidocaine.
PROCEDURE	Conventional opioid-based anesthesia	Conventional opioid-based anesthesia group will be sedated using remi-fentanyl

Timeline

• Start date: 2021-12-16
• Primary completion: 2026-07-31
• Completion: 2027-10-31
• First posted: 2021-12-07
• Last updated: 2025-11-21

Locations

1 site across 1 country: South Korea