NCT02046317

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started May 2011

Longer than P75 for phase_4 pain

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 7, 2018

Completed
Last Updated

December 7, 2018

Status Verified

October 1, 2018

Enrollment Period

5.5 years

First QC Date

December 17, 2013

Results QC Date

November 11, 2018

Last Update Submit

November 11, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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.

Drug: Femoral Nerve BlockDevice: Echogenic needleDevice: Ultrasound

Standard of care needle

ACTIVE COMPARATOR

The control group will receive ultrasound-guided femoral nerve block using standard of care needles.

Drug: Femoral Nerve BlockDevice: Standard of care needleDevice: Ultrasound

Interventions

Femoral Nerve BlockDRUG

Femoral Nerve Block for isolated femur fractures

Echogenic needleStandard of care needle
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.

Echogenic needle
Standard of care needleDEVICE

The control group will receive ultrasound-guided femoral nerve block using standard of care needles.

Standard of care needle
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.

Echogenic needleStandard of care needle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026, United States

Location

Memorial Hermann Hospital Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (16)

  • 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.

    PMID: 20006206BACKGROUND

  • 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.

    PMID: 18358935BACKGROUND

  • 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.

    PMID: 17214918BACKGROUND

  • 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.

    PMID: 18020079BACKGROUND

  • 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.

    PMID: 12548273BACKGROUND

  • Haddad FS, Williams RL. Femoral nerve block in extracapsular femoral neck fractures. J Bone Joint Surg Br. 1995 Nov;77(6):922-3.

    PMID: 7593107BACKGROUND

  • 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.

    PMID: 22915864BACKGROUND

  • 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.

    PMID: 14525749BACKGROUND

  • 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.

    PMID: 17456684BACKGROUND

  • 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.

    PMID: 9840855BACKGROUND

  • 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.

    PMID: 9322469BACKGROUND

  • 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.

    PMID: 8015121BACKGROUND

  • 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.

    PMID: 18829935BACKGROUND

  • 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.

    PMID: 20345356BACKGROUND

  • 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.

    PMID: 20642733BACKGROUND

  • 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.

    PMID: 7074406BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Carlos J Roldan, MD
Organization
The University of Texas Health Science Center at Houston
Carlos.J.Roldan@uth.tmc.edu
713-745-7246

Study Officials

  • Carlos J Roldan, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - Emergency Medicine

Study Record Dates

First Submitted

December 17, 2013

First Posted

January 27, 2014

Study Start

May 1, 2011

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 7, 2018

Results First Posted

December 7, 2018

Record last verified: 2018-10

Locations

US(2)