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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Fracture
• Intervention / Treatment: Drug: Ropivacaine; Device: Ultrasound; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
      • Kuala Lumpur General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Ropivacaine; Fascia iliaca compartment block using ropivacaine; Device: Ultrasound; Ultrasound-guided fascia iliaca compartment block
Active Comparator: 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	Drug: Fentanyl; Intravenous fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
Adverse effects		Up to 24 hours of intervention

Collaborators and Investigators

• Sponsor: Kuala Lumpur General Hospital
• Collaborators: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Study Chair: Raha Abdul Rahman, MBBS, Universiti Kebangsaan Malaysia Medical Centre; Principal Investigator: Azrin Mohd Azidin, MBBS, Kuala Lumpur General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: fentanyl; fascia iliaca compartment block
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Ropivacaine
• Other Study ID Numbers: NMRR-15-757-25608