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

December 27, 2024 updated by: Taner Abdullah, Istanbul Saglik Bilimleri University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34480
        • Basaksehir Cam ve Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESP group
The group that received erector spinae plane block
Procedure: Erector Spinae Plane Block
ESPB was applied to the patients in a sitting position. A high-frequency linear probe was used. Under sterile conditions, the USG probe was placed longitudinally approximately 2 cm lateral to the T4 spinous process. Skin, subcutaneous fat tissue, m. trapezius, rhomboid muscles, erector group muscles, transverse process, intercostal muscles, pleura and lung movements were visualized from superficial to deep structures. 1 ml of 2% lidocaine was injected into the estimated needle entry area. Then, with the block needle the m. trapezius, mm. rhomboidei and erector spinae muscles were passed in order with the in-plane method and the needle was brought into contact with the transverse process. Fascial separation was confirmed with 1-2 ml of saline solution and the block was performed by injecting 20 ml of 0.375% bupivacaine. The distribution of the drug was confirmed by observing it with USG.
Experimental: PECS group
The group that received PECSI-II blocks
Procedure: Pectoral Nerve Block

The PECSI and PECSII blocks were applied concurrently.

In patients who will undergo PECS II, sterile conditions were prepared with the arm on the side to be operated on in the supine position and 90 degrees of abduction. The lateral and pectoral branches of the thoracoacromial artery were visualized between the PM and Pm muscles at the level of the 4th rib under USG guidance. The blocking needle was directed between the PM and Pm muscles for PECS I, 1-2 ml of saline was injected to verify fascial spread, and 10 ml of 0.375% bupivacaine was applied. Afterwards, fascial spread was confirmed by injecting 1-2 ml of saline between the pectoralis minor muscle and the serratur anterior muscle, and PECS II was performed by injecting 10 ml of 0.375% concentration bupivacaine. The distribution of the drug was confirmed by observing it with USG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
First hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional opioid analgesic requirement in the postanesthesia care unit
Time Frame: First hour after surgery
Patients who scored 4 and above in the pain score were administered 10 mg meperidine.
First hour after surgery
Total opioid consumption after discharging from postanesthesia care unit
Time Frame: 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.
Between 1-24 hours after surgery
Visual Analog Scale (VAS) during 24 hours follow-up after surgery
Time Frame: 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".
1th, 4th, 6th, 12th, and 24th hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Saglik Bilimleri University

Investigators

  • Study Chair: Funda Gümüş Özcan, Prof, Basaksehir Cam ve Sakura State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.02.44

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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