Back to resultsAnalgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia
Primary Purpose
Femoral Fracture
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Ropivacaine
Fentanyl
Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Fracture focused on measuring fascia iliaca compartment block, fentanyl
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
Sites / Locations
- Kuala Lumpur General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
fascia iliaca compartment block
intravenous fentanyl
Arm Description
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
Patient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia
Outcomes
Primary Outcome Measures
Pain score during positioning
Pain score is assessed using Visual Analogue Scale (VAS) score
Secondary Outcome Measures
Ease of positioning for spinal anaesthesia
It will be characterized as 'very difficult', 'difficult', 'easy' and 'very easy'
Patient satisfaction
Patient will be asked whether they will choose the same analgesic technique in the event of future operation : 'yes' or 'no'.
Adverse effects
Full Information
NCT ID
NCT02983344
First Posted
November 29, 2016
Last Updated
September 5, 2017
Sponsor
Kuala Lumpur General Hospital
Collaborators
Universiti Kebangsaan Malaysia Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT02983344
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuala Lumpur General Hospital
Collaborators
Universiti Kebangsaan Malaysia Medical Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fracture
Keywords
fascia iliaca compartment block, fentanyl
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fascia iliaca compartment block
Arm Type
Active Comparator
Arm Description
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
Arm Title
intravenous fentanyl
Arm Type
Active Comparator
Arm Description
Patient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Fascia iliaca compartment block using ropivacaine
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Intravenous fentanyl
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound-guided fascia iliaca compartment block
Primary Outcome Measure Information:
Title
Pain score during positioning
Description
Pain score is assessed using Visual Analogue Scale (VAS) score
Time Frame
Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
Secondary Outcome Measure Information:
Title
Ease of positioning for spinal anaesthesia
Description
It will be characterized as 'very difficult', 'difficult', 'easy' and 'very easy'
Time Frame
Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
Title
Patient satisfaction
Description
Patient will be asked whether they will choose the same analgesic technique in the event of future operation : 'yes' or 'no'.
Time Frame
24 hours after intervention
Title
Adverse effects
Time Frame
Up to 24 hours of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raha Abdul Rahman, MBBS
Organizational Affiliation
Universiti Kebangsaan Malaysia Medical Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Azrin Mohd Azidin, MBBS
Organizational Affiliation
Kuala Lumpur General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuala Lumpur General Hospital
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50586
Country
Malaysia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25068412
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.
Results Reference
result
PubMed Identifier
19650803
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.
Results Reference
result
PubMed Identifier
23789738
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.
Results Reference
result
PubMed Identifier
33238043
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.
Results Reference
derived
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Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia
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