Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia

Sponsor

Kuala Lumpur General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02983344

Collaborator

Universiti Kebangsaan Malaysia Medical Centre (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Femoral Fracture	Drug: Ropivacaine Drug: Fentanyl Device: Ultrasound	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Ropivacaine Fascia iliaca compartment block using ropivacaine Device: Ultrasound Ultrasound-guided fascia iliaca compartment block
Active Comparator: 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	Drug: Fentanyl Intravenous fentanyl

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Ropivacaine

Fascia iliaca compartment block using ropivacaine

Device: Ultrasound

Ultrasound-guided fascia iliaca compartment block

Active Comparator: 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

Drug: Fentanyl

Intravenous fentanyl

Outcome Measures

Primary Outcome Measures

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

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'
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'.
Adverse effects [Up to 24 hours of intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuala Lumpur General Hospital	Kuala Lumpur	Wilayah Persekutuan	Malaysia	50586

Sponsors and Collaborators

Kuala Lumpur General Hospital
Universiti Kebangsaan Malaysia Medical Centre

Investigators

Study Chair: Raha Abdul Rahman, MBBS, Universiti Kebangsaan Malaysia Medical Centre
Principal Investigator: Azrin Mohd Azidin, MBBS, Kuala Lumpur General Hospital