Femoral Neck FracturesPhase 2FNBNCT01701414
Ultrasound-guided Femoral Nerve Blocks in Elderly Patients With Hip Fractures
A Phase 2 study testing Femoral nerve block: 25 mL of 0.5% bupivacaine in people with Femoral Neck Fractures and Hip Fractures, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if ultrasound guided femoral nerve blocks (localized anesthesia in the upper thigh) provide effective pain relief in adult patients with hip fractures in the emergency department and to determine if femoral nerve blocks can then be used to reduce the use of injected analgesia… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Femoral Neck Fractures, Hip Fractures
- What is being tested?
- Femoral nerve block: 25 mL of 0.5% bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Adults over age 55
- Able to understand and give informed consent
- Comfortable with the experimental protocol as outlined to them by the RA or physician investigator
- Have radiologically confirmed hip fractures: femoral head, femoral neck intertrochanteric, or subtrochanteric femur fractures
Who cannot join
- Femoral artery grafts on the same side as the fracture
- Extensive lower extremity trauma
- Concurrent tibia-fibula fractures
- Hypersensitivity to local anesthetics or morphine
- Neurovascular injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Ultrasound-guided Femoral Nerve Blocks in Elderly Patients With Hip Fractures: a Randomized Controlled Clinical Study
The purpose of this study is to determine if ultrasound guided femoral nerve blocks (localized anesthesia in the upper thigh) provide effective pain relief in adult patients with hip fractures in the emergency department and to determine if femoral nerve blocks can then be used to reduce the use of injected analgesia (anesthesia), therefore also causing fewer adverse effects associated with injected analgesia (such as bruising at the site of injection).
100 patients with hip fractures will be enrolled in the study. Patients will be randomly assigned to receive a femoral nerve block (FNB) plus injected analgesia or standard care (SC), which is injected analgesia alone.
Read more
Using guidance from an ultrasound machine, the FNB group will have 20ml of 0.5% bupivacaine (a local anesthetic of long duration) injected into the front of the thigh, at the site of pain. Patients randomized to the SC group will receive an injection of saline (saltwater) so that no neither the patient or the treating physician knows to which group the patient was randomized. All blocks will be performed in the emergency department by an emergency physician trained in the use of ultrasound and ultrasound guided nerve blocks.
Subjects will be asked to rate their pain on a numeric pain scale both before and after intervention (30 min, 60 min, 12 hrs and 24 hrs after injection, as long as the patient is in the ER still). Additional data to be collected includes demographics, vital signs, and course of treatment resulting from the ED visit.
Hypothesis: US-guided femoral nerve blocks can provide effective pain control and possibly decrease or eliminate the need for narcotics.
Read the detailed description
Hip fractures are a significant cause of morbidity and mortality in the elderly. In the acute setting, safe and effective pain control is of the utmost importance. At present, this is typically achieved with the use of parenteral opioids. However in older individuals, who often have other medical comorbidities, the use of narcotics for pain control must be balanced with their potentially deleterious consequences: namely respiratory depression, hypotension, and mental confusion. Both poor pain control and the use of opioid medications have been associated with acute confusional states in the elderly. 1,2 Regional anesthesia can possibly provide adjunctive or even alternative pain control that is both safe and effective.Femoral nerve blocks, using local anesthetics, have been described as a method to reduce pain and the requirement for systemic analgesia, specifically opioids. Prior research has demonstrated feasibility and effective pain control of the femoral nerve block in the ED setting. Bedside ultrasound (US) can be used to precisely visualize the femoral neurovascular anatomy when performing a femoral nerve block and has distinct advantages when performing this procedure in the ED setting.
Study Objectives The primary aim of this study is to determine the relative effectiveness of ultrasound guided femoral nerve blocks in older adult patients with hip fractures in the emergency department as compared with parenteral narcotics alone. A secondary aim of this study is to determine if femoral nerve blocks reduce both the use of parenteral narcotics and the incidence adverse effects associated with parenteral analgesia (delirium, hypotension, respiratory depression) in hip fracture patients both in the emergency department and during their hospital stay.
- Conditions
- Femoral Neck Fractures, Hip Fractures
- Being tested
- Femoral nerve block: 25 mL of 0.5% bupivacaine, Placebo: 3cc of 0.9% Normal Saline
- Keywords
- Femur, Hip, Fracture, Femoral neck, Femoral head
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve block: 25 mL of 0.5% bupivacaineDrug
25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks.
Placebo: 3cc of 0.9% Normal SalineDrug
1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Standard Care (SC) | Sham comparator | The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice. Receives: Drug: Placebo: 3cc of 0.9% Normal Saline |
| Femoral Nerve Block (FNB) | Experimental | Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name "3-in-1 femoral block" is often used), providing maximum analgesia to the hip. Receives: Drug: Femoral nerve block: 25 mL of 0.5% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting at Least One NRS Rating
Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.
Measured: 30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startNov 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Otto Liebmann, MD, Principal investigator, Rhode Island HospitalFrancesca Beaudoin, MD, MS, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701414
- Sponsor's protocol ID
- 210423
- Acronym
- FNB
- Status last verified
- Feb 2008
- First submitted
- 27 Sep 2012
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Femoral Nerve Blocks in Elderly Patients With Hip Fractures: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT01701414
- Acronym / sponsor ID
- FNB / 210423
- Conditions
- Femoral Neck Fractures, Hip Fractures
- Keywords
- Femur, Hip, Fracture, Femoral neck, Femoral head
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Posted 7 Feb 2014
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 determine if ultrasound guided femoral nerve blocks (localized anesthesia in the upper thigh) provide effective pain relief in adult patients with hip fractures in the emergency department and to determine if femoral nerve blocks can then be used to reduce the use of injected analgesia (anesthesia), therefore also causing fewer adverse effects associated with injected analgesia (such as bruising at the site of injection).
100 patients with hip fractures will be enrolled in the study. Patients will be randomly assigned to receive a femoral nerve block (FNB) plus injected analgesia or standard care (SC), which is injected analgesia alone.
Using guidance from an ultrasound machine, the FNB group will have 20ml of 0.5% bupivacaine (a local anesthetic of long duration) injected into the front of the thigh, at the site of pain. Patients randomized to the SC group will receive an injection of saline (saltwater) so that no neither the patient or the treating physician knows to which group the patient was randomized. All blocks will be performed in the emergency department by an emergency physician trained in the use of ultrasound and ultrasound guided nerve blocks.
Subjects will be asked to rate their pain on a numeric pain scale both before and after intervention (30 min, 60 min, 12 hrs and 24 hrs after injection, as long as the patient is in the ER still). Additional data to be collected includes demographics, vital signs, and course of treatment resulting from the ED visit.
Hypothesis: US-guided femoral nerve blocks can provide effective pain control and possibly decrease or eliminate the need for narcotics.
Detailed description
Hip fractures are a significant cause of morbidity and mortality in the elderly. In the acute setting, safe and effective pain control is of the utmost importance. At present, this is typically achieved with the use of parenteral opioids. However in older individuals, who often have other medical comorbidities, the use of narcotics for pain control must be balanced with their potentially deleterious consequences: namely respiratory depression, hypotension, and mental confusion. Both poor pain control and the use of opioid medications have been associated with acute confusional states in the elderly. 1,2 Regional anesthesia can possibly provide adjunctive or even alternative pain control that is both safe and effective.Femoral nerve blocks, using local anesthetics, have been described as a method to reduce pain and the requirement for systemic analgesia, specifically opioids. Prior research has demonstrated feasibility and effective pain control of the femoral nerve block in the ED setting. Bedside ultrasound (US) can be used to precisely visualize the femoral neurovascular anatomy when performing a femoral nerve block and has distinct advantages when performing this procedure in the ED setting.
Study Objectives The primary aim of this study is to determine the relative effectiveness of ultrasound guided femoral nerve blocks in older adult patients with hip fractures in the emergency department as compared with parenteral narcotics alone. A secondary aim of this study is to determine if femoral nerve blocks reduce both the use of parenteral narcotics and the incidence adverse effects associated with parenteral analgesia (delirium, hypotension, respiratory depression) in hip fracture patients both in the emergency department and during their hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care (SC) | Sham comparator | Drug: Placebo: 3cc of 0.9% Normal SalineThe SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice. |
| Femoral Nerve Block (FNB) | Experimental | Drug: Femoral nerve block: 25 mL of 0.5% bupivacaineParticipants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name "3-in-1 femoral block" is often used), providing maximum analgesia to the hip. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English speaking
- Adults over age 55
- Able to understand and give informed consent
- Comfortable with the experimental protocol as outlined to them by the RA or physician investigator
- Have radiologically confirmed hip fractures: femoral head, femoral neck intertrochanteric, or subtrochanteric femur fractures
Key exclusion criteria (5 listed)
- Femoral artery grafts on the same side as the fracture
- Extensive lower extremity trauma
- Concurrent tibia-fibula fractures
- Hypersensitivity to local anesthetics or morphine
- Neurovascular 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 |
|---|---|---|
| Femoral nerve block: 25 mL of 0.5% bupivacaine25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks. | Drug | Femoral Nerve Block (FNB) |
| Placebo: 3cc of 0.9% Normal Saline1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice | Drug | Standard Care (SC) |
Primary outcome
Number of Participants Reporting at Least One NRS Rating
Time frame: 30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.
Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Otto Liebmann, MD principal investigator
Rhode Island Hospital
Francesca Beaudoin, MD, MS principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Femoral nerve block: 25 mL of 0.5% bupivacaine in people with Femoral Neck Fractures and Hip Fractures, run by Rhode Island Hospital at 1 site in United States.
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 5 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 12 Mar 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 United States. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting at Least One NRS Rating (time frame: 30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.). 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 NCT01701414, 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 12 Mar 2014.