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Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis (RELIEF-SCC)

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ClinicalTrials.gov Identifier: NCT04614610
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : January 22, 2021
Sponsor:
Collaborators:
St. Barnabas Medical Center
Newark Beth Israel Medical Center
Monmouth Medical Center
Information provided by (Responsible Party):
Andrew Vassallo, Community Medical Center, Toms River, NJ

Brief Summary:
Sickle cell crisis continues to be a frequent presentation to emergency departments. Patients presenting will often require immediate treatment for their pain and often times this will include opioids. The opioid epidemic has cost thousands of lives; and continues to be a significant problem posing several challenges when treating patients presenting with sickle cell disease. Primarily, opioids remain the mainstay of treatment for these patients and the push to address the opioid crisis may present challenges for adequate opioid administration in patients suffering from a sickle cell crisis while hospitals find ways to curb the opioid crisis overall. Opioid treatment for patients in acute vaso-occlusive crisis has significantly contributed to quality of life and life expectancy of patients with this diagnosis. Measures should continue to attempt to administer a multi-model approach to sickle cell patients to minimize the morphine milligram equivalents in these patients while also successfully addressing the patient's pain. IV lidocaine is a pain medication that has been evaluated in several painful experiences, such as in renal colic. A few case reports have shown IV lidocaine use in sickle cell can be a potential effective adjunct medication to opioids to treat pain and reduce further opioid requirements. Currently, no prospective controlled trial exists to evaluate the true benefit of IV lidocaine in this population. Our study aims to evaluate IV lidocaine as an adjunct to opioid treatment in the emergency department to determine if improved pain is achieved and if there is a reduction in overall morphine milligram equivalents throughout the emergency department visit.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Sickle Cell Crisis Pain, Acute Drug: Lidocaine Iv Drug: Placebo Phase 2

Detailed Description:

Pain is the most frequent reason for emergency department visits in the United States, especially for those patients with sickle cell disease (SCD). Painful vaso-occlusive events frequently require admission to the hospital despite opioid therapy, which is the mainstay of treatment for moderate to severe pain in SCD. Achieving adequate pain control with escalating doses of opioid analgesics may be difficult due to tolerance, physical dependence, and side effects. Common side effects include pruritus, nausea and vomiting, constipation, urinary retention, sedation, and respiratory depression. With the recent focus on the opiate crisis there has been a push towards the use of alternative to opiates (ALTO) for a variety of pain syndromes.

Lidocaine is a class 1b sodium channel blocking agent that is typically used as an anti-arrhythmic and local anesthetic. This medication also has potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic properties. Lidocaine may be useful as an adjunct to opioids in response to a painful sickle cell crisis. Intravenous (IV) lidocaine infusion has previously shown benefit in neuropathic pain, renal colic, and peri-operative pain. No prospective studies have evaluated lidocaine for SCD pain thus far.

A previous retrospective study evaluated lidocaine infusion as adjuvant therapy to patients with SCD. Eleven patients were given a total of 15 IV lidocaine trials. Investigators found clinical improvement in pain score from pre-lidocaine challenge to 24 hours post (defined as a >20% reduction in pain scores) in 53.3% (8 of 15) of patients. Of the 8 clinically successful trials, the mean reduction in morphine dose equivalents (MDE) from 24 hours pre to 24 hours post lidocaine was 32.2%. Two patients experienced disorientation and dizziness. The authors concluded that lidocaine was able to provide pain relief and reduce the amount of morphine necessary during SCD vaso-occlusive crisis and that prospective studies are needed to determine its true efficacy, dosing, and tolerability.

A prospective, single-arm, phase II trial evaluated lidocaine 5% patches for neuropathic pain and pain related to vaso-occlusive sickle cell crises in children ages 6 to 21 years old. Patches were applied to the painful area for 12 hours a day. The primary endpoint was the proportion of inpatients with significant pain relief defined as a decrease of at least 2 points on the visual analog pain scale (VAS, from 0-10) measured at 12 hours after patch placement over two consecutive days. The use of additional treatments such as antiepileptics and opioids were allowed and their usage was documented. The primary outcome of VAS improvement of >2 over 2 consecutive days was observed in 48.6% of evaluated patients (19/39). Transdermal lidocaine was tolerated well with only 3 minor adverse events reported (two localized skin reactions and one generalized skin eruption) and no serious adverse events.

The theoretical benefits along with the two previously discussed studies provide evidence to further investigate the use of lidocaine in SCD pain. Studies are needed to know whether lidocaine may be able to benefit alleviate pain quicker and minimize need for opiates similarly to its use in renal colic. This prospective trial aims to evaluate whether lidocaine can decrease the opiate needs during a SCD crisis while providing adequate pain relief and tolerability.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients presenting to the emergency department for an acute sickle cell crisis who are refractory to one dose of intravenous opiate therapy will be randomized to either lidocaine 1.5mg/kg (max: 200mg) or matching dextrose placebo along with either morphine 0.1-0.15mg/kg IV or hydromorphone 0.01-0.02mg/kg IV.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Lidocaine or placebo will be dispensed from the pharmacy in identical bags labeled "Lidocaine (x)mg or Placebo". The pharmacy will maintain randomization and blinding until the end of the study.
Primary Purpose: Treatment
Official Title: Randomized Trial Evaluating Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis - RELIEF-SCC
Actual Study Start Date : November 3, 2020
Estimated Primary Completion Date : November 2, 2021
Estimated Study Completion Date : February 1, 2022


Arm Intervention/treatment
Active Comparator: Lidocaine
Lidocaine 1.5mg/kg (Max: 200mg) in dextrose 5% 100mL over 10 minutes along with either morphine 0.1-0.15mg/kg IV OR hydromorphone 0.01-0.02mg/kg IV.
Drug: Lidocaine Iv
Lidocaine 1.5mg/kg (Max dose: 200mg) in Dextrose 5% 100mL over 10 minutes

Placebo Comparator: Placebo
Dextrose 5% 100mL (placebo) over 10 minutes along with either morphine 0.1-0.15mg/kg IV OR hydromorphone 0.01-0.02mg/kg IV.
Drug: Placebo
Dextrose 5% 100mL over 10 minutes




Primary Outcome Measures :
  1. Change in pain at 30 minutes [ Time Frame: from pre-lidocaine infusion to 30 minutes post-infusion ]
    Change of visual analog pain scale (VAS, 0-10) at 30 minutes post-infusion of lidocaine or placebo.


Secondary Outcome Measures :
  1. Total opiate dosage received [ Time Frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours) ]
    Total morphine mg equivalents (MME) of opiate received normalized to patient's bodyweight during their ED stay.

  2. % Patients requiring additional opiate administration [ Time Frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours) ]
    Percentage of patients requiring an additional opiate after the lidocaine vs. placebo.

  3. Time to next opiate administered [ Time Frame: from administration of lidocaine infusion until patient disposition (up to 12 hours) or next opiate administered ]
    Time (minutes) until next opiate is administered after lidocaine vs. placebo.

  4. Total MME post-lidocaine up to 12 hours [ Time Frame: 12 hours post-lidocaine or placebo infusion. ]
    Total MME needed after lidocaine vs placebo up to 12 hours

  5. Percentage of patients discharged from ED [ Time Frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours) ]
    Percentage of patients discharged from the ED.

  6. Percentage of patients receiving a >20% reduction in pain scale [ Time Frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours) ]
    Percentage of patients receiving a >20% reduction in pain scale based on the VAS (0-10).

  7. Change in visual analog pain scale (VAS, 0-10 with 10 being the most pain) at 60 and 90 minutes [ Time Frame: 60 and 90 minutes ]
    Change in VAS at 60 and 90 minutes post-infusion.

  8. Number of adverse effects of treatment [ Time Frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours) ]
    Reported adverse effects during study treatment period



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients > 18 years old with sickle cell disease experiencing persistent severe (7-10/10) pain despite receiving at least one dose of intravenous opiate analgesic.

Exclusion Criteria:

  • Patients < 18 years old and pregnant
  • Patients presenting with or suspected to have acute chest syndrome
  • Allergy or intolerance to lidocaine products or morphine/hydromorphone

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): NCT04614610


Contacts
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Contact: Andrew V Vassallo, PharmD 732-557-8070 Andrew.Vassallo@rwjbh.org
Contact: Kristine Sobolewski, PharmD 973-322-2928 kristine.sobolewski@rwjbh.org

Locations
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United States, New Jersey
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Kristine Sobolewski, PharmD       Kristine.Sobolewski@rwjbh.org   
Monmouth Medical Center Not yet recruiting
Long Branch, New Jersey, United States, 07740
Contact: Harisios Tjionas, MD       harisios.tjionas@gmail.com   
Contact: Nicole Keegan, DNP       Nicole.Keegan@rwjbh.org   
Newark Beth Israel Medical Center Not yet recruiting
Newark, New Jersey, United States, 07112
Contact: Shreni Zinzuwadia, MD       zinzuwsh@gmail.com   
Contact: Patrick Hinfey, MD       Patrick.Hinfey@rwjbh.org   
Sponsors and Collaborators
Community Medical Center, Toms River, NJ
St. Barnabas Medical Center
Newark Beth Israel Medical Center
Monmouth Medical Center
Investigators
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Principal Investigator: Shreni Zinzuwadia, MD Newark Beth Israel
Publications:
Lexicomp Online, Lexi-Drugs Online, Hudson, Ohio: Lexi-Comp, Inc.; December 15, 2017.
Eipe N, Gupta S, Penning J. Intravenous Lidocaine for Acute Pain: an Evidence-based Clinical Update. BJA Education,16(9):292-298(2016). Doi: 10.1093/bjaed/mkw008

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Responsible Party: Andrew Vassallo, Primary Research Coordinator, Community Medical Center, Toms River, NJ
ClinicalTrials.gov Identifier: NCT04614610    
Other Study ID Numbers: 20-58
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Andrew Vassallo, Community Medical Center, Toms River, NJ:
lidocaine
ALTO
sickle cell pain
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action