NCT01904071

Brief Summary

Hip Fracture (HFx) is a painful injury that is often treated in the Emergency Department (ED) with intravenous opiates. However, this class of medications may cause deleterious side effects. An alternative analgesic approach involves regional anesthesia. The investigators attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNBs) could be safely performed in an ED setting, (2) whether UPNBs would be more effective than standard treatment in controlling pain from HFx and (3) which of two UPNBs was superior for pain relief. A convenience sample of patients with an isolated HFx and a pain score \> 5/10 were enrolled and randomized to one of three arms: (1) Ultrasound guided 3-in-1 femoral nerve block (UFNB), (2) Ultrasound guided fascia iliaca compartment block (UFIB), or (3) IVMS. Patients indicated their pain from 0 (no pain) to 10 (extreme pain).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 24, 2014

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

July 17, 2013

Results QC Date

December 26, 2013

Last Update Submit

May 7, 2018

Conditions

Hip Fracture

Keywords

Hip FractureUltrasoundNerve Block

Outcome Measures

Primary Outcomes (1)

  • Pain Score at 30 Minutes

    Pain Score at 30 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

    30 minutes

Secondary Outcomes (1)

  • Pain Score at 60 Minutes

    60 minutes

Other Outcomes (3)

  • Pain Score at 120 Minutes

    120 minutes

  • Pain Score at 240 Minutes

    240 minutes

  • Pain Score at 480 Minutes

    480 minutes

Study Arms (3)

UFNB

EXPERIMENTAL

Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.

Procedure: UFNB (Ultrasound guided femoral nerve block)

UFIB

EXPERIMENTAL

Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.

Procedure: UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)

IVMS

ACTIVE COMPARATOR

IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg

Drug: IVMS (IV Morphine)

Interventions

UFNB (Ultrasound guided femoral nerve block)PROCEDURE

Ultrasound Guided Femoral Nerve Block

UFNB
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)PROCEDURE
UFIB
IVMS (IV Morphine)DRUG

Intravenous Morphine

IVMS

Eligibility Criteria

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

You may qualify if:

  • English speaking patients
  • ≥18 years of age
  • radiographic evidence of hip fracture
  • Patients must be awake, alert and oriented to time, place and person.
  • pain score of ≥ 5 in 10 point scale.

You may not qualify if:

  • cognitive deficits
  • allergic to amide-type local anesthetic or morphine
  • more injuries than just hip fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (14)

  • Department of Health and Human Services, the Centers for Disease control, 2004

    BACKGROUND

  • Hwang U, Richardson LD, Sonuyi TO, Morrison RS. The effect of emergency department crowding on the management of pain in older adults with hip fracture. J Am Geriatr Soc. 2006 Feb;54(2):270-5. doi: 10.1111/j.1532-5415.2005.00587.x.

    PMID: 16460378BACKGROUND

  • 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

  • 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

  • Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. doi: 10.1093/bja/aem100. Epub 2007 May 3.

    PMID: 17478453BACKGROUND

  • 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

  • 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

  • Reid N, Stella J, Ryan M, Ragg M. Use of ultrasound to facilitate accurate femoral nerve block in the emergency department. Emerg Med Australas. 2009 Apr;21(2):124-30. doi: 10.1111/j.1742-6723.2009.01163.x.

    PMID: 19422409BACKGROUND

  • Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.

    PMID: 17413915BACKGROUND

  • Wathen JE, Gao D, Merritt G, Georgopoulos G, Battan FK. A randomized controlled trial comparing a fascia iliaca compartment nerve block to a traditional systemic analgesic for femur fractures in a pediatric emergency department. Ann Emerg Med. 2007 Aug;50(2):162-71, 171.e1. doi: 10.1016/j.annemergmed.2006.09.006. Epub 2007 Jan 8.

    PMID: 17210208BACKGROUND

  • Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13.

    PMID: 2589650BACKGROUND

  • Dolan J, Williams A, Murney E, Smith M, Kenny GN. Ultrasound guided fascia iliaca block: a comparison with the loss of resistance technique. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):526-31. doi: 10.1016/j.rapm.2008.03.008.

    PMID: 19258967BACKGROUND

  • Haines L, Dickman E, Ayvazyan S, Pearl M, Wu S, Rosenblum D, Likourezos A. Ultrasound-guided fascia iliaca compartment block for hip fractures in the emergency department. J Emerg Med. 2012 Oct;43(4):692-7. doi: 10.1016/j.jemermed.2012.01.050. Epub 2012 Apr 9.

    PMID: 22494596RESULT

  • Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

    PMID: 33238043DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Morphine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. Eitan Dickman, Director of EM Ultrasound
Organization
Maimonides Medical Center
edickman@maimonidesmed.org
718-283-6057

Study Officials

  • Eitan Dickman, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 22, 2013

Study Start

October 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

June 6, 2018

Results First Posted

April 24, 2014

Record last verified: 2014-05

Locations

US(1)