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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705726
• Other study ID #: 524/2022
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: October 2023
• Source: Minia University
• Contact: hassan m. hetta, lecturer
• Phone: 1010901114
• Email: hassan.hetta[@]mu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Aged 18-60 years.

2. Hip fractures

3. Both sexes.

Exclusion Criteria:

1. Patient refusal

2. Allergy to local anesthetics

3. Bleeding diathesis or history of anticoagulant use.

4. impaired cognition or dementia

5. . Infection of the skin at the site of needle punctures area

6. multiple fractures

7. Any previous analgesic administration during the last 12 hours

Related Conditions & MeSH terms

• Analgesia
• Femoral Fractures
• Pain

Intervention

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

Drug:
• Intravenous drug
Patient will received intravenous injection of precedex 0.25mic/Kg and ketamine 0,2 mg/kg .

Locations

Country	Name	City	State
Egypt	Minia University Hospital	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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