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

Study Overview
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Brief Summary
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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.

Detailed Description
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Study population All of patients will undergo mastectomy with or without immediate breast reconstruction. 230 patients will be enrolled. Intervention OFA group will be sedated using dexmedetomidine and lidocaine. Conventional opioid anesthesia group will be sedated using remifentanil. Pain screening Breast Cancer Pain Questionnaire (BCPQ) 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)

Official Title
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A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia

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

Intervention / Treatment
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* Procedure: Opioid-free anesthesia
* Procedure: Conventional opioid-based anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control arm: Conventional Anesthesia with opioid Interventional arm: Opiod-free Anesthesia with dexmedetomidine and lidocaine
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid-free anesthesia group<br>OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy. | Procedure: Opioid-free anesthesia<br>* OFA group will be sedated using dexmedetomidine and lidocaine.<br>* Other names: Dexmedetomidine and lidocaine-based anesthesia;|
| Active Comparator: Conventional anesthesia group with opioid<br>Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy. | Procedure: Conventional opioid-based anesthesia<br>* Conventional opioid-based anesthesia group will be sedated using remi-fentanyl<br>* Other names: Remi-fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of chronic breast pain at 1 year after mastectomy | Presence of 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. | 1 year after mastectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | 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 | 
| Pain Sensitivity | 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 |