Open Technique Erector Spinae Plane Block in Spinal Surgery | NCT06157762

Studies
Open Technique Erector Spinae Plane Block in Spinal Surgery

NCT06157762

Sponsor

Kahramanmaras Sutcu Imam University

Status

Unknown status

Last Update Posted

Dec 6, 2023Actual

Enrollment

56Estimated

Phase

Not Applicable

Conditions

Postoperative Pain
Erector Spinae Plane Block in Spinal Surgery

Interventions

Erector spinae plane block
Erector spinae plane block performed by surgeon

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2023Estimated

Primary Completion Date

Oct 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Nov 27, 2023

First Submission Date that Met QC Criteria

Nov 27, 2023

First Posted Date

Dec 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Dec 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gökçe Gişi, Assistant Professor, Kahramanmaras Sutcu Imam UniversityPrincipal Investigator

Lead Sponsor

Kahramanmaras Sutcu Imam UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESPB performed by surgeon	Experimental	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	Active Comparator	The ultrasound-guided erector spinae plane block will be applied preoperatively.	Procedure: Erector spinae plane block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector spinae plane block	Procedure	ultrasound guided lumbar erector spinae plane block	Erector spinae plane block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D010146	Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

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