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

NCT ID: NCT05705726

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-11
• Study Completion Date: 2024-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

facia iliaca block

Group Type: EXPERIMENTAL

ultrasound guided facia iliaca block

Intervention Type: DEVICE

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

Precedex and ketamine

Group Type: EXPERIMENTAL

Intravenous drug

Intervention Type: DRUG

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

Interventions

ultrasound guided facia iliaca block

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

Intervention Type: DEVICE

Intravenous drug

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Hassan Mokhtar Elshorbagy Hetta

lecturer of anesthesia and ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hassan m. hetta, lecturer

Role: PRINCIPAL_INVESTIGATOR

Minia University, faculty of medicine

Locations

Minia University Hospital

Minya, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hassan m. hetta, lecturer

Role: CONTACT

hassan.hetta@mu.edu.eg

1010901114 ext. 0020

Facility Contacts

hassan m. hetta, lecturer

Role: primary

hassan.hetta@mu.edu.eg

1010901114 ext. 0020

Other Identifiers

524/2022

Identifier Type: -

Identifier Source: org_study_id