Erector Spina Plane Block for Multilevel Major Spinal Sur... | NCT05983393

Studies
Erector Spina Plane Block for Multilevel Major Spinal Surgery

NCT05983393

Sponsor

Kahramanmaras Sutcu Imam University

Status

Completed

Last Update Posted

Oct 10, 2023Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Pain
Post Operative Pain

Interventions

Erector spinae plane block
Control

Countries

Turkey (Türkiye)

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Aug 7, 2023Actual

Completion Date

Aug 7, 2023Actual

First Submitted Date

Aug 1, 2023

First Submission Date that Met QC Criteria

Aug 1, 2023

First Posted Date

Aug 9, 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

Oct 6, 2023

Last Update Posted Date

Oct 10, 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. This study aims to examine the postoperative analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation

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.

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

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Sham Comparator	No block was performed	Procedure: Control
Erector spinae plane block	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector spinae plane block	Procedure	Erector spinae plane block was performed	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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gökce Gişi	Kahramanmaras Sutcu Imam Universty	Principal Investigator
Gözen Öksüz	Kahramanmaras Sutcu Imam Universty	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kahramanmaras Sutcu Imam University Hospital		Kahramanmaraş		46100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided