Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia

NCT ID: NCT02983344

Last Updated: 2017-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-06-30

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.

Conditions

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Femoral Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Fascia iliaca compartment block using ropivacaine

Ultrasound

Intervention Type DEVICE

Ultrasound-guided fascia iliaca compartment block

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Intravenous fentanyl

Interventions

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Ropivacaine

Fascia iliaca compartment block using ropivacaine

Intervention Type DRUG

Fentanyl

Intravenous fentanyl

Intervention Type DRUG

Ultrasound

Ultrasound-guided fascia iliaca compartment block

Intervention Type DEVICE

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role collaborator

Kuala Lumpur General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr Aida Mastura Mohd Shah

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raha Abdul Rahman, MBBS

Role: STUDY_CHAIR

Universiti Kebangsaan Malaysia Medical Centre

Azrin Mohd Azidin, MBBS

Role: PRINCIPAL_INVESTIGATOR

Kuala Lumpur General Hospital

Locations

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Kuala Lumpur General Hospital

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.

Reference Type RESULT
PMID: 25068412 (View on PubMed)

Yun MJ, Kim YH, Han MK, Kim JH, Hwang JW, Do SH. Analgesia before a spinal block for femoral neck fracture: fascia iliaca compartment block. Acta Anaesthesiol Scand. 2009 Nov;53(10):1282-7. doi: 10.1111/j.1399-6576.2009.02052.x. Epub 2009 Jul 22.

Reference Type RESULT
PMID: 19650803 (View on PubMed)

Newman B, McCarthy L, Thomas PW, May P, Layzell M, Horn K. A comparison of pre-operative nerve stimulator-guided femoral nerve block and fascia iliaca compartment block in patients with a femoral neck fracture. Anaesthesia. 2013 Sep;68(9):899-903. doi: 10.1111/anae.12321. Epub 2013 Jun 21.

Reference Type RESULT
PMID: 23789738 (View on PubMed)

Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

Reference Type DERIVED
PMID: 33238043 (View on PubMed)

Other Identifiers

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NMRR-15-757-25608

Identifier Type: -

Identifier Source: org_study_id

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