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

Phase 3

Recruiting

• Conditions: Breast Cancer; Pain, Post Operative; Mastectomy; Pain, Chronic
• Interventions: Procedure: Opioid-free anesthesia; Procedure: Conventional opioid-based anesthesia

• Registration Number: NCT05146778
• Lead Sponsor: Gangnam Severance Hospital

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.

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 Timeline

• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-07
• Study Start: 2021-12-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-25
• Primary Completion: 2024-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 230

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid-free anesthesia group	Opioid-free anesthesia	OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy.
Conventional anesthesia group with opioid	Conventional opioid-based anesthesia	Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy.

Primary Outcome Measures

Name	Time	Method
Presence of chronic breast pain at 1 year after mastectomy	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life	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.
Pain Sensitivity	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".

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of