Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
NCT ID: NCT02046317
Last Updated: 2018-12-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
12 participants
INTERVENTIONAL
2011-05-31
2016-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Echogenic needle
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.
Femoral Nerve Block
Femoral Nerve Block for isolated femur fractures
Echogenic needle
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.
Ultrasound
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.
Standard of care needle
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Femoral Nerve Block
Femoral Nerve Block for isolated femur fractures
Standard of care needle
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Ultrasound
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.
Interventions
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Femoral Nerve Block
Femoral Nerve Block for isolated femur fractures
Echogenic needle
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 needle
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Ultrasound
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Carlos Roldan
Associate Professor - Emergency Medicine
Principal Investigators
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Carlos J Roldan, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Lyndon Baines Johnson General Hospital
Houston, Texas, United States
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, United States
Countries
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References
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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.
Bijur 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.
Brull 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.
Deam 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.
Fletcher 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.
Haddad FS, Williams RL. Femoral nerve block in extracapsular femoral neck fractures. J Bone Joint Surg Br. 1995 Nov;77(6):922-3.
Iamaroon 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.
Lee 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.
Marhofer 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.
Marhofer 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.
Marhofer 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.
Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA. 1994 Jul 13;272(2):122-4.
Mutty 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.
Saygi 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.
Terrell 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.
Tondare AS, Nadkarni AV. Femoral nerve block for fractured shaft of femur. Can Anaesth Soc J. 1982 May;29(3):270-1. doi: 10.1007/BF03007129.
Other Identifiers
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HSC-MS-11-0035
Identifier Type: -
Identifier Source: org_study_id