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Clinical Trials/NCT02983344
NCT02983344
Completed
Not Applicable

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

Kuala Lumpur General Hospital1 site in 1 country24 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Ropivacaine
Conditions
Femoral Fracture
Sponsor
Kuala Lumpur General Hospital
Enrollment
24
Locations
1
Primary Endpoint
Pain score during positioning
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
June 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kuala Lumpur General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Aida Mastura Mohd Shah

Principle Investigator

Kuala Lumpur General Hospital

Eligibility Criteria

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

Arms & Interventions

fascia iliaca compartment block

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

Intervention: Ropivacaine

fascia iliaca compartment block

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

Intervention: Ultrasound

intravenous fentanyl

Patient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia

Intervention: Fentanyl

Outcomes

Primary Outcomes

Pain score during positioning

Time Frame: 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 Outcomes

  • Ease of positioning for spinal anaesthesia(Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl))
  • Adverse effects(Up to 24 hours of intervention)
  • Patient satisfaction(24 hours after intervention)

Study Sites (1)

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