Peroperative Effect of Regional Anesthesia in Hip Surgery | NCT05960253

Studies
Peroperative Effect of Regional Anesthesia in Hip Surgery

NCT05960253

Sponsor

Ankara City Hospital Bilkent

Status

Unknown status

Last Update Posted

Nov 28, 2023Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Analgesia

Interventions

Pericapsular Nerve Group Block
Lumber Erector Spinae Plane Block

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2023Actual

Primary Completion Date

Sep 1, 2023Actual

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Jul 18, 2023

First Submission Date that Met QC Criteria

Jul 18, 2023

First Posted Date

Jul 25, 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 26, 2023

Last Update Posted Date

Nov 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Levent Öztürk, Professor Doctor, Ankara City Hospital BilkentPrincipal Investigator

Lead Sponsor

Ankara City Hospital BilkentOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A total of 120 patients scheduled for surgical operation due to hip fracture were divided into two randomized groups. The first group received pericapsular nerve group (PENG) block, while the second group received lumbar erector spinae plane (L-ESP) block prior to the surgery. Subsequently, all patients were positioned in the lateral decubitus position before spinal anesthesia and compared in terms of anesthesia effectiveness through pain scores.

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PENG block group	Active Comparator		Procedure: Pericapsular Nerve Group Block
L-ESP group	Experimental		Procedure: Lumber Erector Spinae Plane Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pericapsular Nerve Group Block	Procedure	1st group to be applied PENG block	PENG block group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analgesia	Pain measurement via Visual Analog Scale (VAS) scores	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- American Society of Anesthesiologists(ASA) 2-3 patients undergoing surgery due to hip fracture.

Exclusion Criteria:

Patients in whom regional anesthesia is contraindicated.
Patients who are unable to communicate.
Patients with a known allergy to local anesthetics.
Patients with organ failure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara City Hospital	Recruiting	Ankara		06800	Turkey (Türkiye)

Type	Date	Date Unknown
Release	Aug 5, 2024
Reset	Oct 24, 2024

Submission Tracking

Estimated Results First Submitted Date

Aug 5, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 5, 2024			Oct 24, 2024

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided