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

Primary Purpose

Pain, Analgesia

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

ultrasound guided facia iliaca block

Intravenous drug

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Minia University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

facia iliaca block

Precedex and ketamine

Arm Description

Outcomes

Primary Outcome Measures

Behavioral pain scale

0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, and 4 = unable to proceed because of restlessness or agitation

Secondary Outcome Measures

Quality of patient's position

0 = poor hip flexion, 1 = satisfactory hip flexion, 2 = good hip flexion, and 3 = optimal hip flexion

Full Information

NCT ID

NCT05705726

First Posted

January 20, 2023

Last Updated

October 18, 2023

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05705726

Brief Title

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

Official Title

Ultrasound Guided Fascia Iliaca Block Versus Intravenous Dexmedetomidine and Ketamine for Positioning Fracture Femur Patients During Spinal Anesthesia: Randomized Comparison Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2023 (Actual)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Analgesia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

facia iliaca block

Arm Type

Experimental

Arm Title

Precedex and ketamine

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

ultrasound guided facia iliaca block

Intervention Description

Patient will received ultrasound guided fascia iliaca block by 20 ml Bupivacaine 0,25% .

Intervention Type

Drug

Intervention Name(s)

Intravenous drug

Intervention Description

Patient will received intravenous injection of precedex 0.25mic/Kg and ketamine 0,2 mg/kg .

Primary Outcome Measure Information:

Title

Behavioral pain scale

Description

0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, and 4 = unable to proceed because of restlessness or agitation

Time Frame

during spinal anesthesia

Secondary Outcome Measure Information:

Title

Quality of patient's position

Description

0 = poor hip flexion, 1 = satisfactory hip flexion, 2 = good hip flexion, and 3 = optimal hip flexion

Time Frame

before spinal anesthesia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

hassan m. hetta, lecturer

Phone

1010901114

Ext

0020

hassan.hetta@mu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

hassan m. hetta, lecturer

Organizational Affiliation

minia university/ faculty of medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Minia University Hospital

City

Minya

ZIP/Postal Code

61511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

hassan m. hetta, lecturer

Phone

1010901114

Ext

0020

hassan.hetta@mu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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