PainPhase 4TUFFENNCT02046317
Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
A Phase 4 study testing Femoral Nerve Block, Echogenic needle and Ultrasound in people with Pain, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
This study aims to determine if there is any difference in the success rate of ultra-sound guided femoral nerve block performed with an echogenic needle versus a standard needle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Femoral Nerve Block, Echogenic needle and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Nov 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present to the emergency department (ED) with isolated femur fracture (no other injuries)
- Patients who are cognitively alert and are able to verbalize their pain using a visual analog scale (VAS)
- Patients who are mentally competent to consent for the study
- Patients who can communicate in English or Spanish
Who cannot join
- Gestation
- Prisoners
- Patients who cannot communicate in English or in Spanish
- Patients who have other significant injuries besides a femur fracture
- Patients who are cognitively impaired and/or unable to verbalize their pain using a visual analog scale (VAS)
- Patients with allergies to local anesthetics
Show all 12Show fewer
- Patients with severe liver disease
- Patients with existing peripheral neuropathies in the affected limb
- Patients with history of complications from previous femoral blocks
- Patients with contraindications for needle insertion at inguinal area
- Local signs of infection
- Patient on anticoagulants and/or with history of coagulation disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, 77030
About this study
This study aims to determine if there is any difference in the success rate of ultra-sound guided femoral nerve block performed with an echogenic needle versus a standard needle.
Read the detailed description
To date, the published information regarding ultrasound guided femoral nerve blocks (FNB) using echo friendly needle is very limited. More so, there is even less information regarding ultrasound guided nerve blocks using echogenic versus standard of care needles.
This study hopes to add to the general knowledge of pain management in the emergency department (ED) setting and provide a unique perspective on ultrasound-guided techniques using echogenic needles to enhance accuracy and success rate of nerve blocks in ED patients.
The study design will have two comparative arms; in both arms we use the same local anesthetic which is Bupivacaine 0.25% with epinephrine; in all cases a total of 15 mL will be injected around the femoral nerve. Once identified with ultrasound, 5 ml will be injected at lateral, medial, and posterior aspect of the nerve. The experimental arm will receive an FNB using an echogenic needle; and the control group will receive an FNB using standard of care needles.
- Conditions
- Pain
- Being tested
- Femoral Nerve Block, Echogenic needle, Standard of care needle, Ultrasound
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nerve BlockDrug
Femoral Nerve Block for isolated femur fractures
Echogenic needleDevice
The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.
Standard of care needleDevice
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
UltrasoundDevice
The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
| Study group | Role | What they receive |
|---|---|---|
| Echogenic needle | Experimental | The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. Receives: Drug: Femoral Nerve Block; Device: Echogenic needle; Device: Ultrasound |
| Standard of care needle | Active comparator | The control group will receive ultrasound-guided femoral nerve block using standard of care needles. Receives: Drug: Femoral Nerve Block; Device: Standard of care needle; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain Level
Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever.
Measured: baseline
Patient Pain Level
Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever.
Measured: 60 minutes after initial femoral block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startMay 2011
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: No further enrolled patients, Primary researcher left the institution
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 (16)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Roldan, The University of Texas Health Science Center, Houston
- Investigators
- Carlos J Roldan, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046317
- Sponsor's protocol ID
- HSC-MS-11-0035
- Acronym
- TUFFEN
- Status last verified
- Oct 2018
- First submitted
- 17 Dec 2013
- Last updated
- 7 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.
PubMed 20006206Bijur P, Berard A, Nestor J, Calderon Y, Davitt M, Gallagher EJ. No racial or ethnic disparity in treatment of long-bone fractures. Am J Emerg Med. 2008 Mar;26(3):270-4. doi: 10.1016/j.ajem.2007.05.010.
PubMed 18358935Brull R, Perlas A, Chan VW. Ultrasound-guided peripheral nerve blockade. Curr Pain Headache Rep. 2007 Feb;11(1):25-32. doi: 10.1007/s11916-007-0018-6.
PubMed 17214918Deam RK, Kluger R, Barrington MJ, McCutcheon CA. Investigation of a new echogenic needle for use with ultrasound peripheral nerve blocks. Anaesth Intensive Care. 2007 Aug;35(4):582-6. doi: 10.1177/0310057X0703500419.
PubMed 18020079Fletcher AK, Rigby AS, Heyes FL. Three-in-one femoral nerve block as analgesia for fractured neck of femur in the emergency department: a randomized, controlled trial. Ann Emerg Med. 2003 Feb;41(2):227-33. doi: 10.1067/mem.2003.51.
PubMed 12548273Haddad FS, Williams RL. Femoral nerve block in extracapsular femoral neck fractures. J Bone Joint Surg Br. 1995 Nov;77(6):922-3.
PubMed 7593107Iamaroon A, Raksakietisak M, Halilamien P, Hongsawad J, Boonsararuxsapong K. Femoral nerve block versus fentanyl: Analgesia for positioning patients with fractured femur. Local Reg Anesth. 2010;3:21-6. doi: 10.2147/lra.s8600. Epub 2010 Mar 25.
PubMed 22915864Lee JS, Hobden E, Stiell IG, Wells GA. Clinically important change in the visual analog scale after adequate pain control. Acad Emerg Med. 2003 Oct;10(10):1128-30. doi: 10.1111/j.1553-2712.2003.tb00586.x.
PubMed 14525749Marhofer P, Chan VW. Ultrasound-guided regional anesthesia: current concepts and future trends. Anesth Analg. 2007 May;104(5):1265-9, tables of contents. doi: 10.1213/01.ane.0000260614.32794.7b.
PubMed 17456684Marhofer P, Schrogendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8. doi: 10.1016/s1098-7339(98)90086-4.
PubMed 9840855Marhofer P, Schrogendorfer K, Koinig H, Kapral S, Weinstabl C, Mayer N. Ultrasonographic guidance improves sensory block and onset time of three-in-one blocks. Anesth Analg. 1997 Oct;85(4):854-7. doi: 10.1097/00000539-199710000-00026.
PubMed 9322469Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA. 1994 Jul 13;272(2):122-4.
PubMed 8015121Mutty CE, Jensen EJ, Manka MA Jr, Anders MJ, Bone LB. Femoral nerve block for diaphyseal and distal femoral fractures in the emergency department. Surgical technique. J Bone Joint Surg Am. 2008 Oct;90 Suppl 2 Pt 2:218-26. doi: 10.2106/JBJS.H.00314.
PubMed 18829935Saygi B, Ozkan K, Eceviz E, Tetik C, Sen C. Skin traction and placebo effect in the preoperative pain control of patients with collum and intertrochanteric femur fractures. Bull NYU Hosp Jt Dis. 2010;68(1):15-7.
PubMed 20345356Terrell KM, Hui SL, Castelluccio P, Kroenke K, McGrath RB, Miller DK. Analgesic prescribing for patients who are discharged from an emergency department. Pain Med. 2010 Jul;11(7):1072-7. doi: 10.1111/j.1526-4637.2010.00884.x.
PubMed 20642733
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
- ClinicalTrials.gov ID
- NCT02046317
- Acronym / sponsor ID
- TUFFEN / HSC-MS-11-0035
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No further enrolled patients, Primary researcher left the institution
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Posted 7 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine if there is any difference in the success rate of ultra-sound guided femoral nerve block performed with an echogenic needle versus a standard needle.
Detailed description
To date, the published information regarding ultrasound guided femoral nerve blocks (FNB) using echo friendly needle is very limited. More so, there is even less information regarding ultrasound guided nerve blocks using echogenic versus standard of care needles.
This study hopes to add to the general knowledge of pain management in the emergency department (ED) setting and provide a unique perspective on ultrasound-guided techniques using echogenic needles to enhance accuracy and success rate of nerve blocks in ED patients.
The study design will have two comparative arms; in both arms we use the same local anesthetic which is Bupivacaine 0.25% with epinephrine; in all cases a total of 15 mL will be injected around the femoral nerve. Once identified with ultrasound, 5 ml will be injected at lateral, medial, and posterior aspect of the nerve. The experimental arm will receive an FNB using an echogenic needle; and the control group will receive an FNB using standard of care needles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echogenic needle | Experimental | Drug: Femoral Nerve Block, Device: Echogenic needle, Device: UltrasoundThe experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. |
| Standard of care needle | Active comparator | Drug: Femoral Nerve Block, Device: Standard of care needle, Device: UltrasoundThe control group will receive ultrasound-guided femoral nerve block using standard of care needles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who present to the emergency department (ED) with isolated femur fracture (no other injuries)
- Patients who are cognitively alert and are able to verbalize their pain using a visual analog scale (VAS)
- Patients who are mentally competent to consent for the study
- Patients who can communicate in English or Spanish
Key exclusion criteria (12 listed)
- Gestation
- Prisoners
- Patients who cannot communicate in English or in Spanish
- Patients who have other significant injuries besides a femur fracture
- Patients who are cognitively impaired and/or unable to verbalize their pain using a visual analog scale (VAS)
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 BlockFemoral Nerve Block for isolated femur fractures | Drug | Echogenic needle, Standard of care needle |
| Echogenic needleThe experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. | Device | Echogenic needle |
| Standard of care needleThe control group will receive ultrasound-guided femoral nerve block using standard of care needles. | Device | Standard of care needle |
| UltrasoundThe experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. The control group will receive ultrasound-guided femoral nerve block using standard of care needles. | Device | Echogenic needle, Standard of care needle |
Primary outcome
Patient Pain Level
Time frame: baseline
Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever.
Patient Pain Level
Time frame: 60 minutes after initial femoral block
Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20006206Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.
- Background: PubMed 18358935Bijur P, Berard A, Nestor J, Calderon Y, Davitt M, Gallagher EJ. No racial or ethnic disparity in treatment of long-bone fractures. Am J Emerg Med. 2008 Mar;26(3):270-4. doi: 10.1016/j.ajem.2007.05.010.
- Background: PubMed 17214918Brull R, Perlas A, Chan VW. Ultrasound-guided peripheral nerve blockade. Curr Pain Headache Rep. 2007 Feb;11(1):25-32. doi: 10.1007/s11916-007-0018-6.
- Background: PubMed 18020079Deam RK, Kluger R, Barrington MJ, McCutcheon CA. Investigation of a new echogenic needle for use with ultrasound peripheral nerve blocks. Anaesth Intensive Care. 2007 Aug;35(4):582-6. doi: 10.1177/0310057X0703500419.
- Background: PubMed 12548273Fletcher AK, Rigby AS, Heyes FL. Three-in-one femoral nerve block as analgesia for fractured neck of femur in the emergency department: a randomized, controlled trial. Ann Emerg Med. 2003 Feb;41(2):227-33. doi: 10.1067/mem.2003.51.
- Background: PubMed 7593107Haddad FS, Williams RL. Femoral nerve block in extracapsular femoral neck fractures. J Bone Joint Surg Br. 1995 Nov;77(6):922-3.
- Background: PubMed 22915864Iamaroon A, Raksakietisak M, Halilamien P, Hongsawad J, Boonsararuxsapong K. Femoral nerve block versus fentanyl: Analgesia for positioning patients with fractured femur. Local Reg Anesth. 2010;3:21-6. doi: 10.2147/lra.s8600. Epub 2010 Mar 25.
- Background: PubMed 14525749Lee JS, Hobden E, Stiell IG, Wells GA. Clinically important change in the visual analog scale after adequate pain control. Acad Emerg Med. 2003 Oct;10(10):1128-30. doi: 10.1111/j.1553-2712.2003.tb00586.x.
- Background: PubMed 17456684Marhofer P, Chan VW. Ultrasound-guided regional anesthesia: current concepts and future trends. Anesth Analg. 2007 May;104(5):1265-9, tables of contents. doi: 10.1213/01.ane.0000260614.32794.7b.
- Background: PubMed 9840855Marhofer P, Schrogendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8. doi: 10.1016/s1098-7339(98)90086-4.
- Background: PubMed 9322469Marhofer P, Schrogendorfer K, Koinig H, Kapral S, Weinstabl C, Mayer N. Ultrasonographic guidance improves sensory block and onset time of three-in-one blocks. Anesth Analg. 1997 Oct;85(4):854-7. doi: 10.1097/00000539-199710000-00026.
- Background: PubMed 8015121Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA. 1994 Jul 13;272(2):122-4.
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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.
Carlos J Roldan, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Femoral Nerve Block, Echogenic needle and Ultrasound in people with Pain, run by The University of Texas Health Science Center, Houston at 2 sites 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Dec 2018). 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?
Patient Pain Level (time frame: baseline). 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 NCT02046317, which also lists 16 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 7 Dec 2018.