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

NCT05705726 | Unknown

• 1 other identifier: 524/2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Analgesia

Outcome Measures

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

  during spinal anesthesia

Secondary Outcomes (1)

• Quality of patient's position

  before spinal anesthesia

Study Arms (2)

facia iliaca block

EXPERIMENTAL

Device: ultrasound guided facia iliaca block

Precedex and ketamine

EXPERIMENTAL

Drug: Intravenous drug

Interventions

ultrasound guided facia iliaca block DEVICE

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

facia iliaca block

Intravenous drug DRUG

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

Precedex and ketamine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-60 years.
• Hip fractures
• Both sexes.

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospital

Minya, 61511, Egypt

RECRUITING

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Infusion Pumps

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• hassan m. hetta, lecturer

  Minia University, faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hassan m. hetta, lecturer

CONTACT

1010901114; hassan.hetta@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and ICU

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: February 11, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)