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

November 18, 2025 updated by: Sung Gwe Ahn, Gangnam Severance Hospital

A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sung Gwe Ahn, M.D.,Ph.D.
  • Phone Number: 82220194402
  • Email: asg2004@yuhs.ac

Study Contact Backup

Study Locations

  • South Korea
      • Seoul, South Korea, 135270
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
          • Sung Gwe Ahn, MD, PhD
          • Phone Number: 82-2-2019-3370
          • Email: asg2004@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Opioid-free anesthesia group
OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy.
Procedure: Opioid-free anesthesia
OFA group will be sedated using dexmedetomidine and lidocaine.
Other Names:
  • Dexmedetomidine and lidocaine-based anesthesia
Active Comparator: Conventional anesthesia group with opioid
Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy.
Procedure: Conventional opioid-based anesthesia
Conventional opioid-based anesthesia group will be sedated using remi-fentanyl
Other Names:
  • Remi-fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chronic breast pain at 1 year after mastectomy
Time Frame: 1 year after mastectomy
chronic pain will be assessed by Breast Cancer Pain Questionnaire (BCPQ). Zero score means absence of persisting breast-related pain. The minimum and maximum values of pain scale are 0 and 11, respectively. High score means worse outcome. Moderating role of preoperative psychosocial factors on the impact of OFA on chronic postoperative pain will be evaluated.
1 year after mastectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Sensitivity
Time Frame: 1 year after mastectomy
The type of pain will be assessed by painDetect Questionnaire (PDQ). The PDQ comprises 12 items. The first three assess current pain, strongest pain during the past 4 weeks, and average pain during the past 4 weeks on a 0-10 point numerical rating scale from "none" to "worst imaginable".
1 year after mastectomy
psychological symptoms
Time Frame: 1 year after mastectomy
Presence of anxiety and depression symptoms will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire. The range of each symptoms scale is between 0 and 21. A scale of 0-7 is defined as normal, a scale of 8-10 is defined as borderline, and a scale of 11-21 is defined as abnormal. High score means worse outcome.
1 year after mastectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Investigators

  • Principal Investigator: Sung Gwe G Ahn, M.D.,Ph.D., Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2021

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0568-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe