Comparison of Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Surgery

June 28, 2021 updated by: Sevim Cesur, Kocaeli University

Comparison of Postoperative Efficacy of Ultrasound-guided Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Cancer Surgery

In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi level erector spinae plane (ESP) block on postoperative analgesic effect in 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 bi- level erector spinae plane block and modified pectoral block.

Study Type

Interventional

Enrollment (Actual)

70

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
      • Kocaeli, Turkey
        • Kocaeli University

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Society of Anesthesiologists Classification (ASA) I-II patients
  • 18-70 aged patients
  • patients who scheuled elective breast cancer surgery

Exclusion Criteria:

  • American Society of Anesthesiologists Classification (ASA) III-IV patients
  • patients with coagulopathy
  • patients with infection at the injection site

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bi-level erector spinae plane block
Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group.
Other: Ultrasound guided bi-level erector spinae plane block
Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group.
EXPERIMENTAL: Modified pectoral nerve block
Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.
Other: Ultrasound guided modified pectoral nerve block
Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphin consumption
Time Frame: during postoperative 24 hour
Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.
during postoperative 24 hour
numerical rating scale (NRS)
Time Frame: during postoperative 24 hour
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
during postoperative 24 hour

Collaborators and Investigators

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

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Sevim Cesur, MD, 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)

January 1, 2020

Primary Completion (ACTUAL)

January 10, 2021

Study Completion (ACTUAL)

January 15, 2021

Study Registration Dates

First Submitted

December 27, 2020

First Submitted That Met QC Criteria

December 27, 2020

First Posted (ACTUAL)

December 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOU KAEK 2018/487

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.

Clinical Trials on Postoperative Pain

Clinical Trials on Ultrasound guided bi-level erector spinae plane block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe