NCT02983344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

November 29, 2016

Last Update Submit

September 5, 2017

Conditions

Femoral Fracture

Keywords

fascia iliaca compartment blockfentanyl

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Ease of positioning for spinal anaesthesia

    Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)

  • Patient satisfaction

    24 hours after intervention

  • Adverse effects

    Up to 24 hours of intervention

Study Arms (2)

fascia iliaca compartment block

ACTIVE COMPARATOR

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: RopivacaineDevice: Ultrasound

intravenous fentanyl

ACTIVE COMPARATOR

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

Interventions

RopivacaineDRUG

Fascia iliaca compartment block using ropivacaine

fascia iliaca compartment block
FentanylDRUG

Intravenous fentanyl

intravenous fentanyl
UltrasoundDEVICE

Ultrasound-guided fascia iliaca compartment block

fascia iliaca compartment block

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuala Lumpur General Hospital

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

Related Publications (4)

  • 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.

    PMID: 25068412RESULT

  • 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.

    PMID: 19650803RESULT

  • 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.

    PMID: 23789738RESULT

  • 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.

    PMID: 33238043DERIVED

MeSH Terms

Conditions

Femoral Fractures

Interventions

RopivacaineFentanylUltrasonography

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Raha Abdul Rahman, MBBS

    Universiti Kebangsaan Malaysia Medical Centre

    STUDY CHAIR

  • Azrin Mohd Azidin, MBBS

    Kuala Lumpur General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 6, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

MY(1)