Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia

Not Applicable

Completed

• Conditions: Femoral Fracture
• Interventions: Drug: Ropivacaine; Drug: Fentanyl; Device: Ultrasound

• Registration Number: NCT02983344
• Lead Sponsor: Kuala Lumpur General Hospital

Brief Summary

This study is performed to determine the efficacy of ultrasound-guided fascia iliaca compartment block during positioning for spinal anaesthesia in patient undergoing repair of proximal femur fracture surgery comparing with intravenous fentanyl.

Detailed Description

This a prospective, single-blind, randomized control study that compare the efficacy of ultrasound-guided fascia iliaca compartment block with intravenous fentanyl in positioning patient with femur fracture for spinal anaesthesia.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-11-29
• Primary Completion: 2016-12
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-06
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• American Society of Anaesthesiologists (ASA) score I and II
• Elective surgery of repair of unilateral, single femoral fracture under spinal anaesthesia performed in General Operation Theatre, Hospital Kuala Lumpur. The fracture may involve femoral neck or femoral shaft.

Exclusion Criteria

• Patient with contraindication for spinal anaesthesia
• Known hypersensitivity or contraindication to medication used in this study
• Morbid obesity (body mass index (BMI) > 35 kg/m2)
• Infection at the intended site of administration of fascia iliaca compartment block
• Patient with impaired cognitive function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fascia iliaca compartment block	Ultrasound	Patient will receive 40ml of ropivacaine 0.375% at the fascia iliaca compartment under the guidance of ultrasound. It will be given 20 minutes before patient is positioned for spinal anaesthesia
fascia iliaca compartment block	Ropivacaine	Patient will receive 40ml of ropivacaine 0.375% at the fascia iliaca compartment under the guidance of ultrasound. It will be given 20 minutes before patient is positioned for spinal anaesthesia
intravenous fentanyl	Fentanyl	Patient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia

Primary Outcome Measures

Name	Time	Method
Pain score during positioning	Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)	Pain score is assessed using Visual Analogue Scale (VAS) score

Secondary Outcome Measures

Name	Time	Method
Ease of positioning for spinal anaesthesia	Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)	It will be characterized as 'very difficult', 'difficult', 'easy' and 'very easy'
Adverse effects	Up to 24 hours of intervention
Patient satisfaction	24 hours after intervention	Patient will be asked whether they will choose the same analgesic technique in the event of future operation : 'yes' or 'no'.

Trial Locations

Locations (1)

Kuala Lumpur General Hospital; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia