NCT05266378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

February 23, 2022

Last Update Submit

January 18, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Intensity of pain

    Postoperative day 0, 1

Other Outcomes (8)

  • Preoperative psychological factors: HADS

    1-5 days before surgery, 1st OPD visit after surgery

  • Preoperative psychological factors: EQ-5D

    1-5 days before surgery, 1st OPD visit after surgery

  • Preoperative psychological factors and pain sensitivity test: PHQ-15

    1-5 days before surgery, 1st OPD visit after surgery

  • +5 more other outcomes

Study Arms (2)

Block group

EXPERIMENTAL

The group undergoing PECs block

Procedure: PECs block

Control group

PLACEBO COMPARATOR

The group not receiving PECs block

Other: Not receiving PECs Block

Interventions

PECs blockPROCEDURE

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.

Block group
Not receiving PECs BlockOTHER

In this group, the PECs block was not implemented.

Control group

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Young Song

Seoul, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33492696BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Young Song

CONTACT

82-2-2019-6692nearmyheart@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 1. Control arm: Conventional Anesthesia 2. Interventional arm: Conventional Anesthesia with pectoralis nerve block.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 4, 2022

Study Start

February 23, 2022

Primary Completion

February 23, 2024

Study Completion

March 24, 2025

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

KR(1)