Hip FracturesNCT05365555
Blind Fascia Iliaca Compartment Block Compared to Ultrasound-guided Femoral Nerve Block in Patients With Hip Fractures
An observational study of Hip Fractures, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The goal of this study is to compare the analgesic effect of a blind fascia iliaca compartment block to an ultrasound-guided femoral nerve block in patients that present to the emergency department with hip fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Fascia Iliaca Compartment Block, Femoral Nerve Block and Ropivacaine
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2022to Apr 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients in the emergency department with a radiologically verified hip fracture eligible for a peripheral nerve block according to local guidelines
Who may be able to join
- Adult emergency department patient over 18 years of age with a radiologically verified fracture classified as hip fracture that are eligible for a peripheral nerve block according to local guidelines
Who cannot join
- Multi-system trauma
- Isolated pelvic or diaphyseal femur fracture
- Patients unable to communicate regardless of reason
- Patients with contraindications to receiving a peripheral nerve block with an amide local anaesthetic according to local guidelines
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Akutmottagningen US Östergötland
Linköping, Östergötland County, 58185
Daniel Wilhelms, PhD, +46101033000, daniel.wilhelms@regionostergotland.se
Erika Hörlin, Msc, +46101033041, erika.horlin@regionostergotland.se
About this study
Official title: Analgesic Effect of Blind Fascia Iliaca Compartment Block Compared to an Ultrasound-guided Femoral Nerve Block in Patients With Hip Fractures
The goal of this study is to compare the analgesic effect of a blind fascia iliaca compartment block to an ultrasound-guided femoral nerve block in patients that present to the emergency department with hip fractures.
Read the detailed description
Hip fractures often present to the emergency department and elderly, already fragile, patients are overrepresented. The pain associated with a hip fracture can be severe and have deleterious effects on the patient. Many studies, and a Cochrane review, have shown that a peripheral nerve block provides good pain relief and has many benefits compared to traditional pain relief, such as intravenous morphine. There is less consensus regarding which kind of nerve block, and which technique, is best to use. Many studies compared different kinds of nerve blocks to traditional methods, or more recently compared different kinds of ultrasound-guided techniques to each other.
This study proposes to compare the widely used technique of a blind fascia iliaca compartment block (FICB) to an ultrasound-guided femoral nerve block (FNB) that is currently being rolled out locally as an alternative. During the implementation period of this new clinical routine, it will be possible to compare the efficacy of FICB and FNB in reducing participant-reported pain.
- Conditions
- Hip Fractures
- Being tested
- Fascia Iliaca Compartment Block, Femoral Nerve 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.
Fascia Iliaca Compartment BlockProcedure or surgery
Also called Peripheral nerve block, Regional anesthesia
Blind technique.
Femoral Nerve BlockProcedure or surgery
Also called Peripheral nerve block, Regional anesthesia
Ultrasound guided.
RopivacaineDrug
Also called Local anesthetic, Naropin
Ropivacaine dosed according to local guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Fascia Iliaca Compartment Block (FICB) | Participants with a radiologically verified hip fracture receiving a FICB using a blind technique guided by anatomical landmarks. Receives: Procedure: Fascia Iliaca Compartment Block; Drug: Ropivacaine | |
| Femoral Nerve Block (FNB) | Participants with a radiologically verified hip fracture receiving a FNB using ultrasound guidance for direct nerve visualisation. Receives: Procedure: Femoral Nerve Block; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Pain Scores on the Numeric Rating Scale (0 to 10, where 10 is Maximum Pain) at 30 minutes after Administration of Block, at Rest and During Active Hip Flexion
Change in reported pain score should be at least one whole unit on the numeric rating scale.
Measured: Measured 30 minutes after administered nerve block.
Secondary outcomes (2)
Ratio of Failed Blocks
Defined by a failure to reduce reported pain 30 minutes after administered block by at least one whole unit on the numeric rating scale
Measured: Through study completion, an average of 1 year
Rate of Complications
Comparing the rate of any reported complication between cohorts
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 May 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Wilhelms, University Hospital, Linkoeping
- Investigators
- Daniel Wilhelms, PhD, MD, Principal investigator, University Hospital, Linköping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365555
- Sponsor's protocol ID
- SE2021-05967-01
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Blind Fascia Iliaca Compartment Block Compared to an Ultrasound-guided Femoral Nerve Block in Patients With Hip Fractures
- ClinicalTrials.gov ID
- NCT05365555
- Acronym / sponsor ID
- SE2021-05967-01
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 9 May 2022 (actual)
- 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 goal of this study is to compare the analgesic effect of a blind fascia iliaca compartment block to an ultrasound-guided femoral nerve block in patients that present to the emergency department with hip fractures.
Detailed description
Hip fractures often present to the emergency department and elderly, already fragile, patients are overrepresented. The pain associated with a hip fracture can be severe and have deleterious effects on the patient. Many studies, and a Cochrane review, have shown that a peripheral nerve block provides good pain relief and has many benefits compared to traditional pain relief, such as intravenous morphine. There is less consensus regarding which kind of nerve block, and which technique, is best to use. Many studies compared different kinds of nerve blocks to traditional methods, or more recently compared different kinds of ultrasound-guided techniques to each other.
This study proposes to compare the widely used technique of a blind fascia iliaca compartment block (FICB) to an ultrasound-guided femoral nerve block (FNB) that is currently being rolled out locally as an alternative. During the implementation period of this new clinical routine, it will be possible to compare the efficacy of FICB and FNB in reducing participant-reported pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia Iliaca Compartment Block (FICB) | – | Procedure: Fascia Iliaca Compartment Block, Drug: RopivacaineParticipants with a radiologically verified hip fracture receiving a FICB using a blind technique guided by anatomical landmarks. |
| Femoral Nerve Block (FNB) | – | Procedure: Femoral Nerve Block, Drug: RopivacaineParticipants with a radiologically verified hip fracture receiving a FNB using ultrasound guidance for direct nerve visualisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients in the emergency department with a radiologically verified hip fracture eligible for a peripheral nerve block according to local guidelines
Key inclusion criteria (1 listed)
- Adult emergency department patient over 18 years of age with a radiologically verified fracture classified as hip fracture that are eligible for a peripheral nerve block according to local guidelines
Key exclusion criteria (4 listed)
- Multi-system trauma
- Isolated pelvic or diaphyseal femur fracture
- Patients unable to communicate regardless of reason
- Patients with contraindications to receiving a peripheral nerve block with an amide local anaesthetic according to local guidelines
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 |
|---|---|---|
| Fascia Iliaca Compartment BlockAlso: Peripheral nerve block, Regional anesthesiaBlind technique. | Procedure or surgery | Fascia Iliaca Compartment Block (FICB) |
| Femoral Nerve BlockAlso: Peripheral nerve block, Regional anesthesiaUltrasound guided. | Procedure or surgery | Femoral Nerve Block (FNB) |
| RopivacaineAlso: Local anesthetic, NaropinRopivacaine dosed according to local guidelines. | Drug | Fascia Iliaca Compartment Block (FICB), Femoral Nerve Block (FNB) |
Primary outcome
Mean Change from Baseline in Pain Scores on the Numeric Rating Scale (0 to 10, where 10 is Maximum Pain) at 30 minutes after Administration of Block, at Rest and During Active Hip Flexion
Time frame: Measured 30 minutes after administered nerve block.
Change in reported pain score should be at least one whole unit on the numeric rating scale.
2 secondary outcomes
Ratio of Failed Blocks
Time frame: Through study completion, an average of 1 year
Rate of Complications
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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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.
Daniel Wilhelms, PhD, MD principal investigator
University Hospital, Linköping
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by University Hospital, Linkoeping at 1 site in Sweden.
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: status not confirmed, as of the sponsor's last update on 9 May 2022. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Leckström, MBBS (+46704555507, daniel.leckstrom@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Pain Scores on the Numeric Rating Scale (0 to 10, where 10 is Maximum Pain) at 30 minutes after Administration of Block, at Rest and During Active Hip Flexion (time frame: Measured 30 minutes after administered nerve block.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2022.