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RecruitingNCT05705726Updated Oct 19, 2023

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

An interventional study of ultrasound guided facia iliaca block and Intravenous drug in Pain and Analgesia, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by Minia University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
  • Analgesia

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03

In context

Femoral Fractures

293 studies on the registry are indexed under Femoral Fractures; 47 are open to participants now.

This study's planned enrollment of 70 is close to the median of 64 across 182 interventional studies indexed under Femoral Fractures.

Browse Femoral Fractures studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18-60 years.
  2. Hip fractures
  3. Both sexes.

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    facia iliaca block

    Device: ultrasound guided facia iliaca block

  • Experimental
    Precedex and ketamine

    Drug: Intravenous drug

Interventions

  • Deviceultrasound guided facia iliaca block

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

  • DrugIntravenous drug

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

06

What researchers measure

Primary outcomes

  1. Behavioral pain scale

    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 outcomes

  1. Quality of patient's position

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

    Time frame: before spinal anesthesia

07

Study locations

1 of 1 sites recruiting
  • Minia University Hospital
    Minya, 61511, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05705726
Lead sponsor
Minia University
Responsible party
Hassan Mokhtar Elshorbagy Hetta (lecturer of anesthesia and ICU, Minia University) — Principal investigator
First posted
Jan 31, 2023
Start date
Feb 11, 2023
Primary completion
Apr 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Oct 19, 2023

Study contacts

hassan m. hetta, lecturer
Contact
hassan.hetta@mu.edu.eg
1010901114 ext. 0020
hassan m. hetta, lecturer
principal investigator · Minia University, faculty of medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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