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

Primary Purpose

Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Femoral Nerve Block
Echogenic needle
Standard of care needle
Ultrasound
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lyndon Baines Johnson General Hospital
  • Memorial Hermann Hospital Texas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Echogenic needle

Standard of care needle

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2013
Last Updated
November 11, 2018
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02046317
Brief Title
Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
Acronym
TUFFEN
Official Title
Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
No further enrolled patients, Primary researcher left the institution
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echogenic needle
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care needle
Arm Type
Active Comparator
Arm Description
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Intervention Type
Drug
Intervention Name(s)
Femoral Nerve Block
Intervention Description
Femoral Nerve Block for isolated femur fractures
Intervention Type
Device
Intervention Name(s)
Echogenic needle
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard of care needle
Intervention Description
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Pain Level
Description
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.
Time Frame
baseline
Title
Patient Pain Level
Description
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.
Time Frame
60 minutes after initial femoral block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos J Roldan, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon Baines Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Facility Name
Memorial Hermann Hospital Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20006206
Citation
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Results Reference
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Citation
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.
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PubMed Identifier
17214918
Citation
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.
Results Reference
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PubMed Identifier
18020079
Citation
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.
Results Reference
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PubMed Identifier
12548273
Citation
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Results Reference
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PubMed Identifier
7593107
Citation
Haddad FS, Williams RL. Femoral nerve block in extracapsular femoral neck fractures. J Bone Joint Surg Br. 1995 Nov;77(6):922-3.
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22915864
Citation
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.
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PubMed Identifier
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Citation
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Citation
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Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles

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