Pectoralis Nerve Block and Quality of Recovery in Mastectomy Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2025-03-24

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.

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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)

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. Control arm: Conventional Anesthesia
2. Interventional arm: Conventional Anesthesia with pectoralis nerve block.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

All researchers other than the anesthesiologist who manage the randomization table and the medical staff in charge of the patient must keep the group assignment blinded until the end of the study.

Study Groups

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Block group

The group undergoing PECs block

Group Type EXPERIMENTAL

PECs block

Intervention Type PROCEDURE

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.

Control group

The group not receiving PECs block

Group Type PLACEBO_COMPARATOR

Not receiving PECs Block

Intervention Type OTHER

In this group, the PECs block was not implemented.

Interventions

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PECs block

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.

Intervention Type PROCEDURE

Not receiving PECs Block

In this group, the PECs block was not implemented.

Intervention Type OTHER

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No