Hip FractureNCT02037633
Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia
A study testing Fentanyl, Fascia iliaca compartment block and ropivacaine in people with Hip Fracture, run by Asklepieion Voulas General Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to compare two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Fentanyl, Fascia iliaca compartment block and ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2012to Feb 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hip fracture
Who cannot join
- contraindications for central nervous blockade
- impaired cognition or dementia
- multiple fractures
- any previous analgesic administration during the last 12 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fascia Iliaca Compartment Block Versus Fentanyl for Positioning Patients With Hip Fractures for Central Nervous Blockade: a Randomized Trial.
The purpose of this study is to compare two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl.
- Conditions
- Hip Fracture
- Being tested
- Fentanyl, Fascia iliaca compartment block, ropivacaine
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Fentanyl IV
Fascia iliaca compartment blockProcedure or surgery
Fascia iliaca compartment block using ropivacaine
ropivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Fascia iliaca compartment block | Active comparator | Not described Receives: Procedure: Fascia iliaca compartment block; Drug: ropivacaine |
| Fentanyl | Active comparator | Not described Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on the Numeric Rating Scale
Measured: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Secondary outcomes (2)
Duration of spinal anesthesia performance
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Measured: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Quality of patient's position
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Measured: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Diakomi, Asklepieion Voulas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037633
- Sponsor's protocol ID
- 478-9227/25-7-2012
- Status last verified
- Jan 2014
- First submitted
- 12 Jan 2014
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19650803Hogh A, Dremstrup L, Jensen SS, Lindholt J. Fascia iliaca compartment block performed by junior registrars as a supplement to pre-operative analgesia for patients with hip fracture. Strategies Trauma Limb Reconstr. 2008 Sep;3(2):65-70. doi: 10.1007/s11751-008-0037-9. Epub 2008 Sep 2.
PubMed 18762870Guay 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 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Compartment Block Versus Fentanyl for Positioning Patients With Hip Fractures for Central Nervous Blockade: a Randomized Trial.
- ClinicalTrials.gov ID
- NCT02037633
- Acronym / sponsor ID
- 478-9227/25-7-2012
- Conditions
- Hip Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Jan 2014 (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.
The purpose of this study is to compare two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl.
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 | Procedure: Fascia iliaca compartment block, Drug: ropivacaine |
| Fentanyl | Active comparator | Drug: Fentanyl |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hip fracture
Key exclusion criteria (4 listed)
- contraindications for central nervous blockade
- impaired cognition or dementia
- multiple fractures
- any previous analgesic administration during the last 12 hours
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 |
|---|---|---|
| FentanylFentanyl IV | Drug | Fentanyl |
| Fascia iliaca compartment blockFascia iliaca compartment block using ropivacaine | Procedure or surgery | Fascia iliaca compartment block |
| ropivacaine | Drug | Fascia iliaca compartment block |
Primary outcome
Pain scores on the Numeric Rating Scale
Time frame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
2 secondary outcomes
Duration of spinal anesthesia performance
Time frame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Quality of patient's position
Time frame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
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 16 Jan 2014.
- Background: 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.
- Background: PubMed 18762870Hogh A, Dremstrup L, Jensen SS, Lindholt J. Fascia iliaca compartment block performed by junior registrars as a supplement to pre-operative analgesia for patients with hip fracture. Strategies Trauma Limb Reconstr. 2008 Sep;3(2):65-70. doi: 10.1007/s11751-008-0037-9. Epub 2008 Sep 2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl, Fascia iliaca compartment block and ropivacaine in people with Hip Fracture, run by Asklepieion Voulas General Hospital at 1 site in Greece.
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 1 inclusion and 4 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 16 Jan 2014. 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 Greece. 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 scores on the Numeric Rating Scale (time frame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)). 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 NCT02037633, which also lists 3 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 16 Jan 2014.