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Clinical Trials/NCT05266378
NCT05266378
Recruiting
Not Applicable

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

Gangnam Severance Hospital1 site in 1 country156 target enrollmentFebruary 23, 2022
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Gangnam Severance Hospital
Enrollment
156
Locations
1
Primary Endpoint
QoR-15
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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

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)

Registry
clinicaltrials.gov
Start Date
February 23, 2022
End Date
March 24, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Song

Associate Professor

Gangnam Severance Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

QoR-15

Time Frame: Postoperative day 1

To compare the difference in the quality of recovery between groups, the QoR-15 questionnaire is administered on the 1st day after surgery.

Secondary Outcomes

  • Intensity of pain(Postoperative day 0, 1)

Study Sites (1)

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