Comparison of Erector Spina Plan Block and Rhomboid Intercostal Block in Breast Surgery

September 25, 2025 updated by: Gulnihal Avci, Kocaeli University

Comparison of Erector Spina Plan Block and Rhomboid Intercostal Block for Postoperative Pain Managment in Patients Undergoing Unilateral Breast Surgery

In this study, the investigators compared ultrasound-guided erector spinae plane (ESP) block and rhomboid intercostal block (RIB) on postoperative analgesic effect in unilateral breast surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks, written consent was obtained from all patients.Patients who meet eligibility requirements will be randomized in a 1:1 ratio to erector spinae plane block and rhomboid intercostal block.

Study Type

Interventional

Enrollment (Actual)

84

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

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

  • Patients who will undergo unilateral breast-conserving surgery (BCS) or modified radical mastectomy (MRM) with or without axillary lymph node dissection
  • Patients undergoing elective surgery
  • ASA (American Society of Anesthesiologists) physical status classification I-III

Exclusion Criteria:

  • Use of anticoagulants
  • Allergy to the medications to be used
  • Patients who use analgesic drugs due to a history of chronic pain
  • ASA (American Society of Anesthesiologists) physical status classification IV-V
  • Patients with psychiatric disorders
  • Presence of infection in the area where the block will be applied
  • Presence of deformity in the patient's spinal, paraspinal and area where the block will be applied
  • The patient does not accept the block application or cannot cooperate with the patient

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector Spinae Plane Block
Ultrasound(US)-guided erector spinae plan block(ESP) with 20 ml 0,25% bupivacaine at T4 vertebra level will performe preoperatively to all patients in the ESP group.
Other: Erector Spinae Plane Block
Ultrasound(US)-guided erector spinae plan block(ESP) with 20 ml 0,25% bupivacaine at T4 vertebra level will performe preoperatively to all patients in the ESP group.
Experimental: Rhomboid Intercostal Block
Ultrasound(US)-guided rhomboid intercostal block(RIB) with 20 ml 0,25% bupivacaine at T5-T6 vertebra level will performe preoperatively to all patients in the RIB group.
Other: Rhomboid Intercostal Block
Ultrasound(US)-guided rhomboid intercostal block(RIB) with 20 ml 0,25% bupivacaine at T5-T6 vertebra level will performe preoperatively to all patients in the RIB group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphin Consumption
Time Frame: during postoperative 24 hours
Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia
during postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale(NRS)
Time Frame: during postoperative 24 hours
A numerical rating scale(NRS) requires the patient to rate their pain on defined scale.For example , 0-10 where 0 is no pain and 10 is the worst pain imaginable.
during postoperative 24 hours

Collaborators and Investigators

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

Sponsor

Kocaeli University

Investigators

  • Study Director: Sevim Cesur Okan, Kocaeli University

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.

Helpful Links

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)

July 1, 2023

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK/08.bI.02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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