Comparison of Postoperative Analgesic Consumption of the Erector Spina Plane Block and Serratus Anterior Plane Block

April 4, 2019 updated by: Ayse Ulgey, TC Erciyes University

Evaluation of the Efficiency of Erector Spina Plane Block and Serratus Anterior Plane Block for Postoperative Thorasic Pain

To evaluate the ability of Erector spina Plane block and Serratus Anterior Plane block to decrease postoperative pain and analgesia requirements in patients undergoing thoracotomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Thoracic wall nerve blocks such as Erector spina Plane block and Serratus Anterior Plane block have become popular for preoperative pain control in patients undergoing thoracotomy.

Study Type

Interventional

Enrollment (Anticipated)

105

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
    • Talas
      • Kayseri, Talas, Turkey, 38100
        • Ayşe Ülgey

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

ASA I- ASA II Patients

Exclusion Criteria:

  • history of allergy to the study medication
  • refusal to participate

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector spinae plane block group (ESP)
Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4 vertebral level will performed preoperatively to patients in the ESP group (Group I).
Procedure: Erector Spinae Plane block ( Group ı)
ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Active Comparator: Serratus Anterior Plane Block Group (SAP)
Single- shot ultrasound (Esaote Mylab30 )guided SAP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) the T4 vertebral level will performed preoperatively to patients in the SAP group( Group II).
Procedure: Serratus Anterior Plane block ( Group ıı)
SAP Block will perform preoperative to all patients in SAP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Placebo Comparator: Control Group
The Control group receive no intervetion ( Group III).
Procedure: Control Group (GROUPIII)
Control group will receive no intervetion. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: 48 hours after surgery
In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 48 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours).
48 hours after surgery
Verbal analog Pain Scores on rest and movement
Time Frame: 48 hours after surgery
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours) in the 48 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidences of adverse effects (like nausea and vomitting)
Time Frame: 48 hours after surgery
Incidences of nausea and vomitting during the 48 hours postoperative period will recorded at 6 time intervals (2,4,6,12,24,48. hours)
48 hours after surgery

Collaborators and Investigators

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

Sponsor

TC Erciyes University

Investigators

  • Study Director: Ayşe Ülgey, MD, TC Erciyes 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.

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 (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

March 23, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identifed individual participant data for all primary and secondary outcome measures will be made aailable.

IPD Sharing Time Frame

Data will be aailable within 10 months of study completion.

IPD Sharing Access Criteria

Data accep requests will be rewiewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Study Data/Documents

  1. Clinical Study Report

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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