A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia
NCT ID: NCT05146778
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
230 participants
INTERVENTIONAL
2021-12-16
2027-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
2. Interventional arm: Opiod-free Anesthesia with dexmedetomidine and lidocaine
PREVENTION
SINGLE
Study Groups
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Opioid-free anesthesia group
OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy.
Opioid-free anesthesia
OFA group will be sedated using dexmedetomidine and lidocaine.
Conventional anesthesia group with opioid
Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy.
Conventional opioid-based anesthesia
Conventional opioid-based anesthesia group will be sedated using remi-fentanyl
Interventions
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Opioid-free anesthesia
OFA group will be sedated using dexmedetomidine and lidocaine.
Conventional opioid-based anesthesia
Conventional opioid-based anesthesia group will be sedated using remi-fentanyl
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
19 Years
80 Years
FEMALE
No
Sponsors
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Gangnam Severance Hospital
OTHER
Responsible Party
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Sung Gwe Ahn
Assocaite Professor
Principal Investigators
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Sung Gwe G Ahn, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Locations
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Gangnam Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-0568-001
Identifier Type: -
Identifier Source: org_study_id
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