Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia

Femoral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983344
• Other study ID #: NMRR-15-757-25608
• Status: Completed
• Phase: N/A
• First received: November 29, 2016
• Last updated: September 5, 2017
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Kuala Lumpur General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fracture
• Femoral Fractures
• Fractures, Bone

Intervention

Drug:
• Ropivacaine
Fascia iliaca compartment block using ropivacaine
• Fentanyl
Intravenous fentanyl

Device:
• Ultrasound
Ultrasound-guided fascia iliaca compartment block

Locations

Country	Name	City	State
Malaysia	Kuala Lumpur General Hospital	Kuala Lumpur	Wilayah Persekutuan

Sponsors (2)

Lead Sponsor	Collaborator
Kuala Lumpur General Hospital	Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

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 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ease of positioning for spinal anaesthesia	It will be characterized as 'very difficult', 'difficult', 'easy' and 'very easy'	Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
Secondary	Patient satisfaction	Patient will be asked whether they will choose the same analgesic technique in the event of future operation : 'yes' or 'no'.	24 hours after intervention
Secondary	Adverse effects		Up to 24 hours of intervention