Clinical trial NCT02983344: Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia
Official title: Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia : Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Fentanyl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Fracture
Keywords: fascia iliaca compartment block
fentanyl
Lead sponsor: Kuala Lumpur General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Universiti Kebangsaan Malaysia Medical Centre
First posted: 2016-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score during positioning
timeFrame: Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
Secondary outcomes:
measure: Ease of positioning for spinal anaesthesia
timeFrame: Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
measure: Patient satisfaction
timeFrame: 24 hours after intervention
measure: Adverse effects
timeFrame: Up to 24 hours of intervention
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Kuala Lumpur General Hospital
state: Wilayah Persekutuan
Study officials:
affiliation: Universiti Kebangsaan Malaysia Medical Centre
name: Raha Abdul Rahman, MBBS
role: STUDY_CHAIR
affiliation: Kuala Lumpur General Hospital
name: Azrin Mohd Azidin, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.