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NCT Number: NCT02983344

Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia

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.

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Key information

Conditions

Femoral Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuala Lumpur General Hospital

Kuala Lumpur, 50586, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Fascia iliaca compartment block using ropivacaine

Fentanyl

Drug

Intravenous fentanyl

Ultrasound

Device

Ultrasound-guided fascia iliaca compartment block

Primary outcomes

  1. 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

  1. Ease of positioning for spinal anaesthesia

    Time frame: 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'

  2. Patient satisfaction

    Time frame: 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'.

  3. Adverse effects

    Time frame: Up to 24 hours of intervention

Sponsors and collaborators

Lead sponsor

Kuala Lumpur General Hospital

Other Gov

Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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