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

Breast Cancer Clinical Trial

— RELIEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146778
• Other study ID #: 2021-0568-001
• Status: Recruiting
• Phase: Phase 3
• Start date: December 16, 2021
• Est. completion date: October 31, 2025

Study information

• Verified date: March 2022
• Source: Gangnam Severance Hospital
• Contact: Sung Gwe Ahn, M.D.,Ph.D.
• Phone: 82220194402
• Email: asg2004[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Chronic Pain
• Mastectomy
• Pain, Chronic
• Pain, Post Operative
• Pain, Postoperative

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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