Pectoralis Nerve Block and Quality of Recovery in Mastectomy Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: PECs block; Other: Not receiving PECs Block

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)

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Song; Phone Number: 82-2-2019-6692; Email: NEARMYHEART@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Young Song
    • Contact: Young Song; Phone Number: 82-2-2019-6629; Email: gsirb@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Block group; The group undergoing PECs block	Procedure: 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.
Placebo Comparator: Control group; The group not receiving PECs block	Other: Not receiving PECs Block; In this group, the PECs block was not implemented.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative psychological factors: HADS	Presence of anxiety and depression symptoms will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire.	1-5 days before surgery, 1st OPD visit after surgery
Preoperative psychological factors: EQ-5D	Presence of anxiety and depression symptoms will be assessed by EQ-5D.	1-5 days before surgery, 1st OPD visit after surgery
Preoperative psychological factors and pain sensitivity test: PHQ-15	Presence of anxiety, depression symptoms and pain sensitivity will be assessed by PHQ-15.	1-5 days before surgery, 1st OPD visit after surgery
Preoperative psychological factors and pain sensitivity test: pain catastrophizing scale	Presence of anxiety, depression symptoms and pain sensitivity will be assessed by pain catastrophizing scale.	1-5 days before surgery, 1st OPD visit after surgery
Preoperative psychological factors: big five inventory	Presence of anxiety and depression symptoms will be assessed by big five inventory.	1-5 days before surgery, 1st OPD visit after surgery
Preoperative psychological factors: HAM-A&D	Presence of anxiety and depression symptoms will be assessed by HAM-A&D.	1-5 days before surgery, 1st OPD visit after surgery
Patient State Index	Depth of anesthesia will be recorded by using frontal electroencephalogram (Patient State Index, The PSi is a processed EEG parameter that is related to the effect of anesthetic agents, and takes into consideration, among other factors: (1) changes in power in various EEG frequency bands; (2) changes in symmetry and synchronization between critical brain regions; and (3) the inhibition of regions of the frontal cortex.) during operation	perioperative period
analgesic nociception index	Intensity of pain will be recorded by using analgesic nociception index during operation	perioperative period

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Publications and helpful links

General Publications

• Abdallah FW, Patel V, Madjdpour C, Cil T, Brull R. Quality of recovery scores in deep serratus anterior plane block vs. sham block in ambulatory breast cancer surgery: a randomised controlled trial. Anaesthesia. 2021 Sep;76(9):1190-1197. doi: 10.1111/anae.15373. Epub 2021 Jan 25.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Anticipated): February 23, 2024
• Study Completion (Anticipated): March 24, 2025

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 3-2021-0468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No