NCT05146778

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
19mo left

Started Dec 2021

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Dec 2021Oct 2027

First Submitted

Initial submission to the registry

September 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

December 16, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

4.6 years

First QC Date

September 23, 2021

Last Update Submit

November 18, 2025

Conditions

Breast CancerMastectomyPain, ChronicPain, Post Operative

Outcome Measures

Primary Outcomes (1)

  • chronic breast pain at 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 Outcomes (2)

  • psychological symptoms

    1 year after mastectomy

  • Pain Sensitivity

    1 year after mastectomy

Study Arms (2)

Opioid-free anesthesia group

ACTIVE COMPARATOR

OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy.

Procedure: Opioid-free anesthesia

Conventional anesthesia group with opioid

ACTIVE COMPARATOR

Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy.

Procedure: Conventional opioid-based anesthesia

Interventions

Opioid-free anesthesiaPROCEDURE

OFA group will be sedated using dexmedetomidine and lidocaine.

Also known as: Dexmedetomidine and lidocaine-based anesthesia
Opioid-free anesthesia group
Conventional opioid-based anesthesiaPROCEDURE

Conventional opioid-based anesthesia group will be sedated using remi-fentanyl

Also known as: Remi-fentanyl
Conventional anesthesia group with opioid

Eligibility Criteria

Age19 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All of patients will undergo mastectomy with or without immediate breast reconstruction.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, 135270, South Korea

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsChronic PainPain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sung Gwe G Ahn, M.D.,Ph.D.

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Gwe Ahn, M.D.,Ph.D.

CONTACT

82220194402asg2004@yuhs.ac

Soong June Bae, M.D.

CONTACT

82220193370mission815815@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will be not aware of which type of anesthesia would be applied during operation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1. Control arm: Conventional Anesthesia with opioid 2. Interventional arm: Opiod-free Anesthesia with dexmedetomidine and lidocaine
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assocaite Professor

Study Record Dates

First Submitted

September 23, 2021

First Posted

December 7, 2021

Study Start

December 16, 2021

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 31, 2027

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)