Recruiting

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

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.

ClinicalTrials.gov IDNCT05146778

PhaseNA

Enrollment230

SponsorGangnam Severance Hospital

Age19 Years

SexFEMALE

I'm interested View official listing

Conditions studied

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

About this study

Interventions

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

Primary outcomes

chronic breast pain at 1 year after mastectomy (1 year after mastectomy)

Eligibility information

Inclusion Criteria: * All of patients will undergo mastectomy with or without immediate breast reconstruction. Exclusion Criteria: * Previous history of breast surgery * Allergy to drug * Other cancer history * Underlying psychologic disorder * Patients with chronic pain requiring pain killers * Baseline SpO2 \<95% * Left ventricular EF \<40% * Bradycardia as HR \<50 bpm * BMI \>35kg/m2 * Pregnant woman

Study locations

Gangnam Severance Hospital, Seoul, 135270 South Korea

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.