Femoral FractureNCT02983344
Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia
A study testing Ropivacaine, Fentanyl and Ultrasound in people with Femoral Fracture, run by Kuala Lumpur General Hospital at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Femoral Fracture
- What is being tested?
- Ropivacaine, Fentanyl and Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Kuala Lumpur General Hospital
Kuala Lumpur, Kuala Lumpur, 50586
About this study
Official title: 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.
Read the 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.
- Conditions
- Femoral Fracture
- Being tested
- Ropivacaine, Fentanyl, Ultrasound
- Keywords
- fascia iliaca compartment block, fentanyl
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Fascia iliaca compartment block using ropivacaine
FentanylDrug
Intravenous fentanyl
UltrasoundDevice
Ultrasound-guided fascia iliaca compartment block
| Study group | Role | What they receive |
|---|---|---|
| fascia iliaca compartment block | Active comparator | 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 Receives: Drug: Ropivacaine; Device: Ultrasound |
| intravenous fentanyl | Active comparator | Patient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score during positioning
Pain score is assessed using Visual Analogue Scale (VAS) score
Measured: Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
Secondary outcomes (3)
Ease of positioning for spinal anaesthesia
It will be characterized as 'very difficult', 'difficult', 'easy' and 'very easy'
Measured: 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'.
Measured: 24 hours after intervention
Adverse effects
Measured: Up to 24 hours of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Femoral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuala Lumpur General Hospital
- Sponsor type
- Other government
- Collaborators
- Universiti Kebangsaan Malaysia Medical Centre
- Responsible party
- Principal investigator, Dr Aida Mastura Mohd Shah, Kuala Lumpur General Hospital
- Investigators
- Raha Abdul Rahman, MBBS, Study chair, Universiti Kebangsaan Malaysia Medical CentreAzrin Mohd Azidin, MBBS, Principal investigator, Kuala Lumpur General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983344
- Sponsor's protocol ID
- NMRR-15-757-25608
- Status last verified
- Sep 2017
- First submitted
- 29 Nov 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25068412Yun 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.
PubMed 19650803Newman 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.
PubMed 23789738Guay 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.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia : Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Fentanyl
- ClinicalTrials.gov ID
- NCT02983344
- Acronym / sponsor ID
- NMRR-15-757-25608
- Conditions
- Femoral Fracture
- Keywords
- fascia iliaca compartment block, fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kuala Lumpur General HospitalOther government
- Collaborators
- Universiti Kebangsaan Malaysia Medical Centre
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fascia iliaca compartment block | Active comparator | Drug: Ropivacaine, Device: UltrasoundPatient 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 |
| intravenous fentanyl | Active comparator | Drug: FentanylPatient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineFascia iliaca compartment block using ropivacaine | Drug | fascia iliaca compartment block |
| FentanylIntravenous fentanyl | Drug | intravenous fentanyl |
| UltrasoundUltrasound-guided fascia iliaca compartment block | Device | fascia iliaca compartment block |
Primary outcome
Pain score during positioning
Time frame: Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
Pain score is assessed using Visual Analogue Scale (VAS) score
3 secondary outcomes
Ease of positioning for spinal anaesthesia
Time frame: Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
Patient satisfaction
Time frame: 24 hours after intervention
Adverse effects
Time frame: Up to 24 hours of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Results publication: PubMed 25068412Diakomi 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 publication: PubMed 19650803Yun 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 publication: PubMed 23789738Newman 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.
- Derived from this study: PubMed 33238043Guay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raha Abdul Rahman, MBBS study chair
Universiti Kebangsaan Malaysia Medical Centre
Azrin Mohd Azidin, MBBS principal investigator
Kuala Lumpur General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine, Fentanyl and Ultrasound in people with Femoral Fracture, run by Kuala Lumpur General Hospital at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score during positioning (time frame: Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983344, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.