Open Technique Erector Spinae Plane Block in Spinal Surgery

November 27, 2023 updated by: Gökçe Gişi, Kahramanmaras Sutcu Imam University

Comparison of the Effectiveness of Preoperative Ultrasound-Guided Erector Spine Plane Block and Erector Spine Plane Block Performed by the Intraoperative Surgeon in Postoperative Analgesia in Patients Undergoing Lumbar Disc Herniation Surgery

Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles.ESPB has been successfully applied as a part of multimodal analgesia in treating postoperative pain in spinal surgery. However, it may be difficult or impossible to perform lumbar ESPB in obese patients or cases of increased lumbar lordosis. This study aims to investigate the effectiveness of ESPB applied by the intraoperative surgeon.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

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
Experimental: ESPB performed by surgeon
The transverse process of the vertebra will be observed by the surgeon intraoperatively. Local anesthetic medication will be applied between the transverse process and the ESP muscle group.
Procedure: Erector spinae plane block performed by surgeon
Erector spinae plane block performed by surgeon
Active Comparator: Erector spinae plane block
The ultrasound-guided erector spinae plane block will be applied preoperatively.
Procedure: Erector spinae plane block
ultrasound guided lumbar erector spinae plane block

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

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 (Estimated)

December 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Estimated)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/26-05

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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