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Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02983344
Enrollment
24
Registered
2016-12-06
Start date
2015-10-31
Completion date
2017-06-30
Last updated
2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Fracture

Keywords

fascia iliaca compartment block, fentanyl

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.

Interventions

DRUGRopivacaine

Fascia iliaca compartment block using ropivacaine

DRUGFentanyl

Intravenous fentanyl

DEVICEUltrasound

Ultrasound-guided fascia iliaca compartment block

Sponsors

Universiti Kebangsaan Malaysia Medical Centre
CollaboratorOTHER
Kuala Lumpur General Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain score during positioningGroup 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)Pain score is assessed using Visual Analogue Scale (VAS) score

Secondary

MeasureTime frameDescription
Ease of positioning for spinal anaesthesiaGroup 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 satisfaction24 hours after interventionPatient will be asked whether they will choose the same analgesic technique in the event of future operation : 'yes' or 'no'.
Adverse effectsUp to 24 hours of intervention

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026