Erector Spina Plane Block for Multilevel Major Spinal Surgery

October 6, 2023 updated by: Gökçe Gişi, Kahramanmaras Sutcu Imam University

Effect of Ultrasound-guided Bilateral Erector Spina Plan Block for Postoperative Analgesia in Patients Undergoing Multilevel Posterior Spinal Instrumentation.

Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative patient-controlled analgesia in the ESP group and control group will be compared with 24-hour morphine consumption and NRS scores at different time points. In addition, the need for rescue analgesics and patient satisfaction will be evaluated.

Study Type

Interventional

Enrollment (Actual)

42

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
      • Kahramanmaras, Turkey, 46100
        • Kahramanmaras Sutcu Imam University 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

Yes

Description

Inclusion Criteria:

  • ASA I-III patients
  • Agreed to participate in the study

Exclusion Criteria:

  • Patients with infection at the injection site
  • Coagulopathy Allergy to amide-type local anesthetics
  • History of peripheral neuropathy
  • Hepatic and/or renal failure
  • Refusing the procedure
  • Patients with heart disease
  • Patients who have previously undergone surgery from the same area

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
Sham Comparator: Control group
No block was performed
Procedure: Control
Erector spinae plane block was not applied.
Active Comparator: Erector spinae plane block
Erector spinae plane block was performed, morphine was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Procedure: Erector spinae plane block
Erector spinae plane block was performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: up to 24 hour
The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
up to 24 hour

Collaborators and Investigators

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

Sponsor

Kahramanmaras Sutcu Imam University

Investigators

  • Principal Investigator: Gökce Gişi, Kahramanmaraş Sütçü İmam Universty
  • Study Director: Gözen Öksüz, Kahramanmaraş Sütçü İmam Universty

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)

September 1, 2021

Primary Completion (Actual)

August 7, 2023

Study Completion (Actual)

August 7, 2023

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/12-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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 Pain

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe