Pectoralis Nerve Block and Quality of Recovery in Mastectomy Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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The Effect of Pectoralis Nerve Block on Quality of Recovery in Patients Undergoing Breast-conservative Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: PECs block
* Other: Not receiving PECs Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control arm: Conventional Anesthesia Interventional arm: Conventional Anesthesia with pectoralis nerve block.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Block group<br>The group undergoing PECs block | Procedure: PECs block<br>* The PECs block is performed immediately after induction of anesthesia, and 0.375% concentration of ropivacaine (carbiropivacaine injection, Fresinius Kavi Korea Co., Ltd.) is used with a 25 G 5 cm (or 8 cm) needle to induce ultrasound-guided pectoralis major (pectoralis major). 10mL (PECs I block) into the fascia between the pectoralis minor muscle) and the pectoralis minor muscle, and 20mL (PECs II block) between the pectoralis minor and serratus anterior muscle.<br>|
| Placebo Comparator: Control group<br>The group not receiving PECs block | Other: Not receiving PECs Block<br>* In this group, the PECs block was not implemented.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoR-15 | To compare the difference in the quality of recovery between groups, the QoR-15 questionnaire is administered on the 1st day after surgery. | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain | Intensity of pain will be recorded by using VAS (0-10). | Postoperative day 0, 1 |