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

RecruitingNot applicableNCT05146778
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

Official title
A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia
Conditions
Interventions
  • Procedure: Opioid-free anesthesia
  • Procedure: Conventional opioid-based anesthesia
Sponsor
Gangnam Severance Hospital
Start date
2021-12-16
Primary completion
2026-07-31
Sex
Female
Age range
from 19 Years to 80 Years
Results posted
No results posted in this snapshot
Countries
South Korea
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05146778