Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia : Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Fentanyl

Conditions
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Femoral Fracture

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Fentanyl
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fascia iliaca compartment block<br>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 | Drug: Ropivacaine<br>* Fascia iliaca compartment block using ropivacaine<br>Device: Ultrasound<br>* Ultrasound-guided fascia iliaca compartment block<br>|
| Active Comparator: intravenous fentanyl<br>Patient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia | Drug: Fentanyl<br>* Intravenous fentanyl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score during positioning | Pain score is assessed using Visual Analogue Scale (VAS) score | Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fascia iliaca compartment block, fentanyl