Fascia Iliaca Block Versus Intravenous Dexmedetomidine an... | NCT05705726

Studies
Fascia Iliaca Block Versus Intravenous Dexmedetomidine and Ketamine for Positioning Fracture Femur

NCT05705726

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Oct 19, 2023Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Pain
Analgesia

Interventions

ultrasound guided facia iliaca block
Intravenous drug

Countries

Egypt

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2023Actual

Primary Completion Date

Apr 1, 2024Estimated

Completion Date

Jul 1, 2024Estimated

First Submitted Date

Jan 20, 2023

First Submission Date that Met QC Criteria

Jan 20, 2023

First Posted Date

Jan 31, 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 18, 2023

Last Update Posted Date

Oct 19, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hassan Mokhtar Elshorbagy Hetta, lecturer of anesthesia and ICU, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Proximal femur fractures are one of the commonest fractures especially in the elderly population. Early surgical fixation is the best analgesic for associated pain. Spinal anesthesia has been favored by many anesthesiologists due to the simplicity of the technique, the better analgesic profile, and the lower incidence of complications like delirium and thromboembolic events. However, severe pain, encountered during positioning for spinal anesthesia, can complicate the technique and worsen the patient experience.

the study aim to compare the analgesic effect of intravenous dexmedetomidine and fascia iliaca block preoperatively to assist positioning patients for performance of spinal anesthesia.

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

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
facia iliaca block	Experimental		Device: ultrasound guided facia iliaca block
Precedex and ketamine	Experimental		Drug: Intravenous drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound guided facia iliaca block	Device	Patient will received ultrasound guided fascia iliaca block by 20 ml Bupivacaine 0,25% .	facia iliaca block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Behavioral pain scale	0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, and 4 = unable to proceed because of restlessness or agitation	during spinal anesthesia

Secondary Outcomes

Measure	Description	Time Frame
Quality of patient's position	0 = poor hip flexion, 1 = satisfactory hip flexion, 2 = good hip flexion, and 3 = optimal hip flexion	before spinal anesthesia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18-60 years.
Hip fractures
Both sexes.

Exclusion Criteria:

Patient refusal
Allergy to local anesthetics
Bleeding diathesis or history of anticoagulant use.
impaired cognition or dementia
. Infection of the skin at the site of needle punctures area
multiple fractures
Any previous analgesic administration during the last 12 hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
hassan m. hetta, lecturer	Contact	1010901114	0020	hassan.hetta@mu.edu.eg

Overall Officials

Name	Affiliation	Role
hassan m. hetta, lecturer	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minia University Hospital	Recruiting	Minya		61511	Egypt

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
D000377	Agnosia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007260	Infusion Pumps

Ancestor Terms

ID	Term
D004864	Equipment and Supplies
D001187	Artificial Organs
D013523	Surgical Equipment

Browse Leaves

Not provided

Browse Branches

Not provided