Hip FracturesNCT05403073
Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department
A study testing Ultrasound guided Suprainguinal Iliac Fascia Nerve Block. in people with Hip Fractures and Pain, Acute, run by Hospital San Carlos, Madrid.
Trial summary
The main objective is to determine if ultrasound guided suprainguinal iliac fascia block leads in better clinical outcomes such as pain management or time to home discharge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures, Pain, Acute, Ultrasound Therapy; Complications
- What is being tested?
- Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Feb 2023
- 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
- Low energy Hip Fracture
Who cannot join
- Don´t meet Inclusion Criteria
- Present any other synchronic fracture.
- Drug allergy for drugs used for nerve blocking
- Skin infection at injection site.
- Contraindication due to comorbidities.
- Pathologic fractures.
- Cognitive impairment
- Do not give his consent.
Trial locations and contacts
No sites are listed yet.
About this study
The main objective is to determine if ultrasound guided suprainguinal iliac fascia block leads in better clinical outcomes such as pain management or time to home discharge.
Read the detailed description
Determining effectiveness in ultrasound guided suprainguinal iliac fascia block as a tool of comfortability of patients with less use of opioids and their side effects and its possible influence in early discharge to home has no evidence in orthopedics literature till today.
Ultrasound becomes an accessible tool at Emergency Departments and Orthopedic Surgeons are increasingly interested its clinical use.
This clinical trial wants to investigate if its use for hip nerve block leads in better clinical outcomes such as pain management or time to home discharge.
- Being tested
- Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.
- Keywords
- Hip Fractures Pain Ultrasound nerve block
- Medical subject headings
- Hip Fractures, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.Procedure or surgery
Pain management at ER Department will be as usually with iv drugs and ultrasound guided Suprainguinal Iliac Fascia Nerve Block.
| Study group | Role | What they receive |
|---|---|---|
| No Nerve Blocking | No intervention | Pain management at ER Department will be as usually with iv drugs and 3 kilogram soft traction. |
| Ultrasound Nerve blocking | Active comparator | Pain management at ER Department will be as usually with iv drugs and ultrasound guided Suprainguinal Iliac Fascia Nerve Block. Receives: Procedure: Ultrasound guided Suprainguinal Iliac Fascia Nerve Block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Control after Ultrasound guided nerve block vs iv painkillers
Using Visual Analogue Scale (1-No pain; 10 -worst pain) measure difference between pain during arrival at Emergency Department and 30 minutes after Ultrasound guided nerve block vs iv painkillers
Measured: During Emergency Department stay (up to 12 hours)
Secondary outcomes (4)
Patient Hip Mobility with tolerable pain
Range of Motion Degrees
Measured: Immediately Before Discharging home assessed up to 2 weeks.
Functionality: Sit to Stand Test
The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds
Measured: Immediately Before Discharging home assessed up to 2 weeks.
Opioid Use
Quantity of Opioid drugs consumed during Hospital stay expressed in Morphine equivalent doses
Measured: Immediately Before Discharging home assessed up to 2 weeks.
Patient Satisfaction
Patient subjective satisfaction in a numeric scale from 1 (completely dissatisfied with pain management) to 10 (highest possible satisfaction with pain management).
Measured: Immediately Before Discharging home assessed up to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionFeb 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borja Alcobía-Díaz MD, PhD, Hospital San Carlos, Madrid
- Investigators
- Borja Alcobía-Díaz, MD, PhD, Principal investigator, Clinical Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403073
- Sponsor's protocol ID
- 22/027-EC_X
- Status last verified
- Jun 2022
- First submitted
- 25 Feb 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Email Contact
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department
- ClinicalTrials.gov ID
- NCT05403073
- Acronym / sponsor ID
- 22/027-EC_X
- Keywords
- Hip Fractures Pain Ultrasound nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 3 Jun 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 main objective is to determine if ultrasound guided suprainguinal iliac fascia block leads in better clinical outcomes such as pain management or time to home discharge.
Detailed description
Determining effectiveness in ultrasound guided suprainguinal iliac fascia block as a tool of comfortability of patients with less use of opioids and their side effects and its possible influence in early discharge to home has no evidence in orthopedics literature till today.
Ultrasound becomes an accessible tool at Emergency Departments and Orthopedic Surgeons are increasingly interested its clinical use.
This clinical trial wants to investigate if its use for hip nerve block leads in better clinical outcomes such as pain management or time to home discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Nerve Blocking | No intervention | –Pain management at ER Department will be as usually with iv drugs and 3 kilogram soft traction. |
| Ultrasound Nerve blocking | Active comparator | Procedure: Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.Pain management at ER Department will be as usually with iv drugs and ultrasound guided Suprainguinal Iliac Fascia Nerve Block. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Low energy Hip Fracture
Key exclusion criteria (8 listed)
- Don´t meet Inclusion Criteria
- Present any other synchronic fracture.
- Drug allergy for drugs used for nerve blocking
- Skin infection at injection site.
- Contraindication due to comorbidities.
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 |
|---|---|---|
| Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.Pain management at ER Department will be as usually with iv drugs and ultrasound guided Suprainguinal Iliac Fascia Nerve Block. | Procedure or surgery | Ultrasound Nerve blocking |
Primary outcome
Pain Control after Ultrasound guided nerve block vs iv painkillers
Time frame: During Emergency Department stay (up to 12 hours)
Using Visual Analogue Scale (1-No pain; 10 -worst pain) measure difference between pain during arrival at Emergency Department and 30 minutes after Ultrasound guided nerve block vs iv painkillers
4 secondary outcomes
Patient Hip Mobility with tolerable pain
Time frame: Immediately Before Discharging home assessed up to 2 weeks.
Functionality: Sit to Stand Test
Time frame: Immediately Before Discharging home assessed up to 2 weeks.
Opioid Use
Time frame: Immediately Before Discharging home assessed up to 2 weeks.
Patient Satisfaction
Time frame: Immediately Before Discharging home assessed up to 2 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No. Email Contact
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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.
Borja Alcobía-Díaz, MD, PhD principal investigator
Clinical Assistant
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided Suprainguinal Iliac Fascia Nerve Block. in people with Hip Fractures and Pain, Acute, run by Hospital San Carlos, Madrid.
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 8 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 3 Jun 2022. 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.
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 Borja Alcobía-Díaz, MD, PhD (913303001 ext. 3638, dralcobiacot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Control after Ultrasound guided nerve block vs iv painkillers (time frame: During Emergency Department stay (up to 12 hours)). 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 3 Jun 2022.