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

October 18, 2023 updated by: Hassan Mokhtar Elshorbagy Hetta, Minia University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Recruiting
        • Minia University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: facia iliaca block
Device: ultrasound guided facia iliaca block
Patient will received ultrasound guided fascia iliaca block by 20 ml Bupivacaine 0,25% .
Experimental: Precedex and ketamine
Drug: Intravenous drug
Patient will received intravenous injection of precedex 0.25mic/Kg and ketamine 0,2 mg/kg .

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: hassan m. hetta, lecturer, minia university/ faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 524/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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