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Clinical Trials/NCT06758765
NCT06758765
Completed
Not Applicable

Comparison of the Effects of the Erector Spinae Plane Block and PECS I-II Blocks on Postoperative Opioid Consumption and Pain Scores of Patients After Breast-conserving Surgery: A Prospective Randomized Controlled Trial

Istanbul Saglik Bilimleri University1 site in 1 country72 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Surgery
Sponsor
Istanbul Saglik Bilimleri University
Enrollment
72
Locations
1
Primary Endpoint
Early postoperative Visual Analog Scale (VAS) scores
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this study is to compare the analgesic effects of ESPB and PECS II blocks in patients undergoing BCS. The main question it aims to answer is:

  • Whether these two different block procedures will create a difference in postoperative pain scores.
  • Comparison of total opioid consumption during the 24-hour postoperative period.

Our study included patients who were female, who were going to undergo elective breast-conserving surgery between March 2022 and August 2022.

Detailed Description

The patients to be included in our study were divided into two groups as ESPB group or PECS II group by an anesthesia assistant independent of the study using a computer-based randomization program one day before the operation. All patients were informed about the block in the preoperative period, the use of the patient-controlled analgesia device to be used after the operation, and Visual Analog Scale (VAS) assessment. (Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain.) On the day of the operation, group envelopes were placed in the patient files to indicate the groups in sealed envelopes. The appropriate anesthesia method was applied to the patient according to the group written on the patient's envelope by the relevant anesthesiologist on duty in the study. Our study was conducted as a randomized controlled and prospective study. VAS scores at 0, 15, 30, 60 minutes postoperatively recorded for the primer output of the study. For the secondary outputs the total amount of analgesic used was recorded from the records of the PCA device. All patients' demographic data, intraoperative hemodynamic data, anesthesia duration, surgical duration and hospital stay, VAS at 4, 6, 12, 24 hours in the service follow-up, rescue analgesic requirements and numbers, nausea-vomiting and developing complications were evaluated and recorded. The evaluations were made by the anesthesiologist who was blind to the groups.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
November 30, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Istanbul Saglik Bilimleri University
Responsible Party
Principal Investigator
Principal Investigator

Taner Abdullah

Principal Investigator

Istanbul Saglik Bilimleri University

Eligibility Criteria

Inclusion Criteria

  • age between 18-70
  • underwent breast conserving surgery

Exclusion Criteria

  • patients with coagulopathy
  • known local anesthetic allergy
  • abnormal liver function tests
  • infection at the planned injection site
  • chronic usage of analgesics
  • under the age of 18
  • over the age of 70
  • ASA (American Society of Anesthesiologists) IV and higher risk classes
  • limited cooperation for Visual Analog Scale (VAS) follow-ups

Outcomes

Primary Outcomes

Early postoperative Visual Analog Scale (VAS) scores

Time Frame: First hour after surgery

The postoperative pain level that evaluated with evaluated with VAS at 0, 15, 30 and 60 minutes. Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain".

Secondary Outcomes

  • Additional opioid analgesic requirement in the postanesthesia care unit(First hour after surgery)
  • Total opioid consumption after discharging from postanesthesia care unit(Between 1-24 hours after surgery)
  • Visual Analog Scale (VAS) during 24 hours follow-up after surgery(1th, 4th, 6th, 12th, and 24th hours postoperatively)

Study Sites (1)

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