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Ultrasound Guided Pain Control Versus Standard Treatment in Emergency Department HIP Fracture Patients

Primary Purpose

Hip Fracture

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
UFNB (Ultrasound guided femoral nerve block)
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)
IVMS (IV Morphine)
Sponsored by
Antonios Likourezos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Hip Fracture, Ultrasound, Nerve Block

Eligibility Criteria

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

Inclusion Criteria:

  1. English speaking patients
  2. ≥18 years of age
  3. radiographic evidence of hip fracture
  4. Patients must be awake, alert and oriented to time, place and person.
  5. pain score of ≥ 5 in 10 point scale.

Exclusion Criteria:

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

Sites / Locations

  • Maimonides Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

UFNB

UFIB

IVMS

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain Score at 60 Minutes
Pain score at 60 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

Full Information

First Posted
July 17, 2013
Last Updated
May 7, 2018
Sponsor
Antonios Likourezos
Collaborators
Emergency Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01904071
Brief Title
Ultrasound Guided Pain Control Versus Standard Treatment in Emergency Department HIP Fracture Patients
Official Title
Ultrasound Guided Femoral (3 in 1) Nerve Block Versus Ultrasound Guided Fascia Iliacus Compartment Block Versus Standard Treatment for Pain Control in Patients With Hip Fractures in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Antonios Likourezos
Collaborators
Emergency Medicine Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Hip fracture (HFx) is a painful orthopedic emergency that commonly presents to the Emergency Department (ED). There are approximately 320,000 HFx diagnosed annually in the United States, with this number expected to increase as the population ages. It has previously been shown that patients with pain from HFx are undermedicated while in the ED, particularly in overcrowded facilities. Current treatment for ED patients who are experiencing pain from acute HFx is often with intravenous morphine sulfate (IVMS). Morphine can have many undesirable side effects, but of particular concern are delirium, hypotension and respiratory depression. These complications may be accentuated in elderly patients and may necessitate increased patient monitoring and greater utilization of limited ED resources.An alternative to systemic opioid analgesia involves peripheral nerve blockade. Anesthesiologists frequently perform nerve blocks in the peri-operative and post-operative period to control pain in patients undergoing hip surgery. Traditionally, nerve stimulators were used to place the nerve block. However, ultrasonography is being used with increasing frequency to facilitate placement of these peripheral nerve blocks. As Emergency Physicians (EP) become more facile with the use of bedside sonography, ultrasound guided peripheral nerve blockade for HFx may be ideally suited for the ED environment, where one injection could control pain for many hours. The 3-in-1 femoral nerve block (FNB), in which anesthetic is injected adjacent to the femoral nerve but also affects the lateral femoral cutaneous and the obturator nerves, has been shown to be as effective as morphine for pain control of HFx in the ED. Sonographic guidance has been shown to increase the success rate of this block, decrease the time to analgesia, decrease the amount of local anesthetic needed to achieve adequate regional anesthesia, and decrease the incidence of inadvertent intravascular injection. To date, there has been limited research describing the utilization of ultrasound guided femoral nerve blocks in an ED setting. Beaudoin et al. performed a feasibility study demonstrating that EP could effectively perform ultrasound guided femoral nerve blocks. Reid et al. found a significantly decreased time to complete analgesia when using sonographic guidance compared to an anatomic landmark technique. In this later study, anesthesia was assessed by checking skin sensation. Neither of these studies utilized a 3-in-1 nerve block, which may provide greater pain relief for patients with HFx. The fascia iliaca compartment block (FIB) is also effective for treating pain due to HFx. It has been shown in the pediatric anesthesia and pediatric emergency medicine literature that it provides adequate analgesia, and may provide more effective analgesia than the FNB for femur fractures in children. Most of the studies describe the FIB being performed using a technique based on anatomic landmarks. One recent study described ultrasound guidance of the FIB (UFIB) increasing the efficacy of the sensory blockade (12). UFIB has not previously been studied in the ED setting. We attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNB) could be safely performed in an ED setting, (2) whether UPNB would be more effective than standard treatment in controlling pain from HFx in which a 2.5 unit decrease in pain scores was considered clinically significant, and (3) which of two UPNB was superior for pain relief.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Hip Fracture, Ultrasound, Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UFNB
Arm Type
Experimental
Arm Description
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.
Arm Title
UFIB
Arm Type
Experimental
Arm Description
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.
Arm Title
IVMS
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
UFNB (Ultrasound guided femoral nerve block)
Intervention Description
Ultrasound Guided Femoral Nerve Block
Intervention Type
Procedure
Intervention Name(s)
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)
Intervention Type
Drug
Intervention Name(s)
IVMS (IV Morphine)
Intervention Description
Intravenous Morphine
Primary Outcome Measure Information:
Title
Pain Score at 30 Minutes
Description
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
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Pain Score at 60 Minutes
Description
Pain score at 60 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
Time Frame
60 minutes
Other Pre-specified Outcome Measures:
Title
Pain Score at 120 Minutes
Description
Pain score at 120 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
Time Frame
120 minutes
Title
Pain Score at 240 Minutes
Description
Pain Score at 240 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
Time Frame
240 minutes
Title
Pain Score at 480 Minutes
Description
Pain score at 480 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
Time Frame
480 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: cognitive deficits allergic to amide-type local anesthetic or morphine more injuries than just hip fracture.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eitan Dickman, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Department of Health and Human Services, the Centers for Disease control, 2004
Results Reference
background
PubMed Identifier
16460378
Citation
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.
Results Reference
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PubMed Identifier
12548273
Citation
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.
Results Reference
background
PubMed Identifier
9840855
Citation
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.
Results Reference
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PubMed Identifier
17478453
Citation
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.
Results Reference
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PubMed Identifier
9322469
Citation
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.
Results Reference
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PubMed Identifier
20006206
Citation
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.
Results Reference
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PubMed Identifier
19422409
Citation
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.
Results Reference
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17413915
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
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. Erratum In: Anesth Analg 1990 Apr;70(4):474.
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Citation
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.
Results Reference
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Citation
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.
Results Reference
derived

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Ultrasound Guided Pain Control Versus Standard Treatment in Emergency Department HIP Fracture Patients

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