Pectoralis Nerve Block and Quality of Recovery in Mastectomy Patients

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: PECs block; Other: Not receiving PECs Block

Study type: Interventional

Funder types: Other

Identifiers

NCT05266378

3-2021-0468

Details and patient eligibility

About

Effects of pectoralis nerve block on quality of recovery after breast surgery has been debated. We hypothesized there might exist relevant psychosocial factor or variable of pain sensitivity which would influence on the benefit of nerve block.

This study aims to assess effect of pectoralis nerve block on QoR-15 score in subgroups stratified by such factors.

Full description

Study population All of patients will undergo partial mastectomy. 140 patients will be enrolled.

Intervention Pectoralis nerve block will be performed in the Block group.

Psychosocial factor screening 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 endpoints Quality of recovery (QoR)-15 Pain visual analogue scale Opioid consumption Breast Cancer Pain Questionnaire (BCPQ)

Enrollment: 156 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 20 to 80 years who underwent partial mastectomy for breast cancer.

Exclusion criteria

• Patients with a history of previous breast surgery
• Patients with a history of adverse reactions to local anesthetics
• Patients with a history of drug addiction
• Patients with cancer other than breast
• Patients with chronic pain who require analgesics
• History of hospitalization for psychiatric disorders
• Preoperative pulse oximetry (SpO2) < 95 %
• Left ventricular ejection fraction < 40%
• Moderate or severe hepatic impairment
• Body mass index over 35 kg/m2
• Blood clotting disorders
• Pregnant/lactating women
• Inability to understand consent forms and answer research questionnaires due to cognitive impairment
• Unable to read consent form (eg illiterate, foreigner, etc.)
• do not perform axillary lymph node dissection

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 2 patient groups, including a placebo group

Block group

Experimental group

Description:

The group undergoing PECs block

Treatment:

Procedure: PECs block

Control group

Placebo Comparator group

Description:

The group not receiving PECs block

Treatment:

Other: Not receiving PECs Block