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

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ClinicalTrials.gov Identifier: NCT01904071
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : April 24, 2014
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
Emergency Medicine Foundation
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

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).


Condition or disease Intervention/treatment Phase
Hip Fracture Procedure: UFNB (Ultrasound guided femoral nerve block) Procedure: UFIB (Ultrasound Guided Fascia Iliaca Compartment Block) Drug: IVMS (IV Morphine) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UFNB
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)
Ultrasound Guided Femoral Nerve Block

Experimental: UFIB
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)
Active Comparator: IVMS
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)
Intravenous Morphine




Primary Outcome Measures :
  1. Pain Score at 30 Minutes [ Time Frame: 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 :
  1. Pain Score at 60 Minutes [ Time Frame: 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


Other Outcome Measures:
  1. Pain Score at 120 Minutes [ Time Frame: 120 minutes ]
    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

  2. Pain Score at 240 Minutes [ Time Frame: 240 minutes ]
    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

  3. Pain Score at 480 Minutes [ Time Frame: 480 minutes ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904071


Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Antonios Likourezos
Emergency Medicine Foundation
Investigators
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Principal Investigator: Eitan Dickman, MD Maimonides Medical Center
Publications of Results:
Other Publications:
Department of Health and Human Services, the Centers for Disease control, 2004

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Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01904071    
Other Study ID Numbers: 08/09/VA09
First Posted: July 22, 2013    Key Record Dates
Results First Posted: April 24, 2014
Last Update Posted: June 6, 2018
Last Verified: May 2014
Keywords provided by Antonios Likourezos, Maimonides Medical Center:
Hip Fracture
Ultrasound
Nerve Block
Additional relevant MeSH terms:
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Emergencies
Fractures, Bone
Hip Fractures
Wounds and Injuries
Disease Attributes
Pathologic Processes
Femoral Fractures
Hip Injuries
Leg Injuries
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents