Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles (TUFFEN)

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: Femoral Nerve Block; Device: Echogenic needle; Device: Ultrasound; Device: Standard of care 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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital Texas Medical Center
    • Houston, Texas, United States, 77026
      • Lyndon Baines Johnson General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Femoral Nerve Block; Femoral Nerve Block for isolated femur fractures; Device: 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.; Device: 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.
Active Comparator: Standard of care needle; The control group will receive ultrasound-guided femoral nerve block using standard of care needles.	Drug: Femoral Nerve Block; Femoral Nerve Block for isolated femur fractures; Device: 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.; Device: Standard of care needle; The control group will receive ultrasound-guided femoral nerve block using standard of care needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	60 minutes after initial femoral block

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Carlos J Roldan, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: November 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures
• Other Study ID Numbers: HSC-MS-11-0035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No