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

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

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer; Pain, Post Operative; Pain, Chronic; Mastectomy
• Intervention / Treatment: Procedure: Opioid-free anesthesia; Procedure: Conventional opioid-based anesthesia

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 Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sung Gwe Ahn, M.D.,Ph.D.; Phone Number: 82220194402; Email: asg2004@yuhs.ac
• Study Contact Backup: Name: Soong June Bae, M.D.; Phone Number: 82220193370; Email: mission815815@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135270
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Sung Gwe Ahn, MD, PhD; Phone Number: 82-2-2019-3370; Email: asg2004@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Sung Gwe G Ahn, M.D.,Ph.D., Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): October 31, 2025

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Narcotics; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Fentanyl; Dexmedetomidine; Lidocaine; Analgesics, Opioid
• Other Study ID Numbers: 2021-0568-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No