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

Yonsei University Health System (YUHS)

Status: Enrolling

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

Treatments: Procedure: Opioid-free anesthesia; Procedure: Conventional opioid-based anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05146778

2021-0568-001

Details and patient eligibility

About

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.

Full 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)

Enrollment: 230 estimated patients

Sex: Female

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Opioid-free anesthesia group

Active Comparator group

Description:

OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy.

Treatment:

Procedure: Opioid-free anesthesia

Conventional anesthesia group with opioid

Active Comparator group

Description:

Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy.

Treatment:

Procedure: Conventional opioid-based anesthesia