Clinical trial

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

Name

524/2022

Description

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.

Trial arms

Trial start

2023-02-11

Estimated PCD

2024-04-01

Trial end

2024-07-01

Status

Recruiting

Treatment

ultrasound guided facia iliaca block

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

Arms:

facia iliaca block

Intravenous drug

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

Arms:

Precedex and ketamine

Size

Primary endpoint

Behavioral pain scale

during spinal anesthesia

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

Updated at

2023-10-19

1 organization

1 product

2 indications

Organization

Product

Indication

Indication