Erector Spinae Plane Block vs. PECS I-II Blocks After Breast-conserving Surgery

Not Applicable

Completed

• Conditions: Breast Cancer Surgery; Breast Conserving Surgery; Erector Spinae Plane Block; Pectoral Nerve (PECS) Block; Visual Analog Scale; Opioid Consumption; Postoperative Pain, Acute

• Registration Number: NCT06758765
• Lead Sponsor: Istanbul Saglik Bilimleri University

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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-11-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• female
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Early postoperative Visual Analog Scale (VAS) scores	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 Outcome Measures

Name	Time	Method
Additional opioid analgesic requirement in the postanesthesia care unit	First hour after surgery	Patients who scored 4 and above in the pain score were administered 10 mg meperidine.
Total opioid consumption after discharging from postanesthesia care unit	Between 1-24 hours after surgery	The PCA device, which was applied to the patients at the 60th minute postoperatively, was left for patient use until the 24th hour postoperatively.
Visual Analog Scale (VAS) during 24 hours follow-up after surgery	1th, 4th, 6th, 12th, and 24th hours postoperatively	VAS values after discharge from the postanesthesia care unit; Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain".

Trial Locations

Locations (1)

Basaksehir Cam ve Sakura City Hospital; 🇹🇷 Istanbul, Turkey