Hip FracturesEarly Phase 1NCT04086914
Fascia Iliaca Compartment Blocks for Pain Control in Hip Fractures
A Early Phase 1 study testing Nerve Block in people with Hip Fractures, run by Medical University of South Carolina.
Trial summary
This study is comparing the use of a peripheral nerve block and standard opioid pain medications in pain control in hip fractures prior to surgery. A peripheral nerve block is a procedure that injects numbing medicine around a nerve to help decrease the pain, motion, and sensation around the painful site temporarily. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Dec 2020
- Phase
- Early Phase 1
- 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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50 or older, low energy hip fracture, acute hip fracture
Who cannot join
- On anticoagulants, hardware present near injection site, preexisting nerve injury.
About this study
Official title: Fascia Iliaca Compartment Blocks to Improve Preoperative Pain Control in Elderly Hip Fractures
This study is comparing the use of a peripheral nerve block and standard opioid pain medications in pain control in hip fractures prior to surgery. A peripheral nerve block is a procedure that injects numbing medicine around a nerve to help decrease the pain, motion, and sensation around the painful site temporarily. The purpose of this study is to evaluate if peripheral nerve blocks are more effective for pain control than just standard opioid pain medication while decreasing the amount of side effects from opioid medication.
- Conditions
- Hip Fractures
- Being tested
- Nerve Block
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve BlockProcedure or surgery
This group will receive a nerve block consisting of 20mL of 5mg/mL ropivicanine and 0.1mL of 10mg'mL dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Non nerve block | No intervention | Receives no nerve block |
| Nerve block | Experimental | Receives nerve block Receives: Procedure: Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Baseline Pain score on Visual analogue scale at initial encounter
pain is measured 1-10, 1 being the lowest and 10 being the highest
Measured: 0-60 minutes
Mean Change from baseline pain score on the visual analogue scale
pain is measured 1-10, 1 being the lowest and 10 being the highest
Measured: 3-8 hours after initial encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Feb 2020
- Primary completion1 Nov 2020
- Study completion1 Dec 2020
Why it stopped: Study withdrawn at PI\'s request. no patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086914
- Sponsor's protocol ID
- 00090054
- Status last verified
- Aug 2024
- First submitted
- 10 Sep 2019
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Compartment Blocks to Improve Preoperative Pain Control in Elderly Hip Fractures
- ClinicalTrials.gov ID
- NCT04086914
- Acronym / sponsor ID
- 00090054
- Conditions
- Hip Fractures
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn at PI\'s request. no patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 12 Sep 2019 (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.
This study is comparing the use of a peripheral nerve block and standard opioid pain medications in pain control in hip fractures prior to surgery. A peripheral nerve block is a procedure that injects numbing medicine around a nerve to help decrease the pain, motion, and sensation around the painful site temporarily. The purpose of this study is to evaluate if peripheral nerve blocks are more effective for pain control than just standard opioid pain medication while decreasing the amount of side effects from opioid medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non nerve block | No intervention | –Receives no nerve block |
| Nerve block | Experimental | Procedure: Nerve BlockReceives nerve block |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 50 or older, low energy hip fracture, acute hip fracture
Key exclusion criteria (1 listed)
- On anticoagulants, hardware present near injection site, preexisting nerve injury.
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 |
|---|---|---|
| Nerve BlockThis group will receive a nerve block consisting of 20mL of 5mg/mL ropivicanine and 0.1mL of 10mg'mL dexamethasone. | Procedure or surgery | Nerve block |
Primary outcome
Mean Baseline Pain score on Visual analogue scale at initial encounter
Time frame: 0-60 minutes
pain is measured 1-10, 1 being the lowest and 10 being the highest
Mean Change from baseline pain score on the visual analogue scale
Time frame: 3-8 hours after initial encounter
pain is measured 1-10, 1 being the lowest and 10 being the highest
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nerve Block in people with Hip Fractures, run by Medical University of South Carolina.
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 1 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: withdrawn, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean Baseline Pain score on Visual analogue scale at initial encounter (time frame: 0-60 minutes). The study lists 2 primary outcomes in all. 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 NCT04086914, which also lists 1 linked publication.
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 4 Sep 2024.