IV Lidocaine for Sickle Cell Crisis

(RELIEF-SCC Trial)

Recruiting at 3 trial locations

Overseen By Shreni Zinzuwadia, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Community Medical Center, Toms River, NJ

Must be taking: Opioids

Disqualifiers: Pregnancy, Acute chest syndrome, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: up to 12 hours

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adding IV lidocaine to your existing opioid treatment for pain management.

What data supports the effectiveness of the drug IV Lidocaine for treating sickle cell crisis?

Research shows that IV lidocaine can help reduce pain in sickle cell disease, with 53.3% of patients experiencing significant pain relief and a reduction in the need for morphine. This suggests that IV lidocaine may be effective in managing pain during sickle cell crises. ^{1 2 3 4 5}

Is IV lidocaine safe for use in humans?

IV lidocaine is generally considered safe in humans when used at recommended doses, with studies showing it has a high therapeutic index (a measure of safety) and plasma concentrations that stay below harmful levels. However, it can cause side effects like dizziness and disorientation, and there is an increased risk of side effects compared to a placebo, though serious adverse events are rare. ^{1 3 6 7 8}

How does the drug IV lidocaine differ from other treatments for sickle cell crisis?

IV lidocaine is unique because it is administered directly into the bloodstream and has been shown to reduce pain and the need for opioids in sickle cell crisis. Unlike traditional pain medications, it works quickly and can provide significant pain relief with a lower risk of side effects like addiction. ^{1 3 4 8 9}

Research Team

Shreni Zinzuwadia, MD

Principal Investigator

Newark Beth Israel

Eligibility Criteria

This trial is for adults over 18 with sickle cell disease who are in severe pain (7-10/10) despite having had at least one dose of IV opioid painkillers. It's not for those under 18, pregnant women, patients with acute chest syndrome, or anyone allergic to lidocaine or morphine/hydromorphone.

Inclusion Criteria

I am over 18 with sickle cell disease and still have severe pain after IV pain medicine.

Exclusion Criteria

I am experiencing or suspected to have acute chest syndrome.

I am under 18 and pregnant.

You are allergic to lidocaine, morphine, or hydromorphone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either lidocaine or placebo infusion along with opioid treatment for pain management during sickle cell crisis in the emergency department

up to 12 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scale assessments and opiate usage

12 hours

Treatment Details

Interventions

• Lidocaine Iv
• Placebo

Trial Overview The study tests if IV lidocaine can help manage severe pain during a sickle cell crisis when added to standard opioid treatment in the emergency department. The goal is to see if it improves pain and reduces the need for opioids.

Participant Groups

Group I: Lidocaine Active Control 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Community Medical Center, Toms River, NJ

Lead Sponsor

Trials

6

Recruited

1,400+

Rutgers Robert Wood Johnson Medical School

Collaborator

Trials

7

Recruited

18,000+

Newark Beth Israel Medical Center

Collaborator

Trials

12

Recruited

1,300+

Monmouth Medical Center

Collaborator

Trials

2

Recruited

300+

Findings from Research

Intravenous lidocaine (IVL) has been shown to reduce postoperative pain and decrease the need for opioids, along with having anti-inflammatory effects, making it potentially beneficial in perioperative settings.

Despite its promising effects in abdominal surgery, the overall quality of evidence for IVL's benefits across various types of surgeries is limited and inconsistent, leading to uncertainty about its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Use of Intravenous Lidocaine. Beaussier, M., Delbos, A., Maurice-Szamburski, A., et al.[2019]

In a study of 60 patients undergoing cytoreductive surgery, intravenous lidocaine was found to be as effective as thoracic epidural anesthesia in managing pain, with lower pain scores at 72 hours post-surgery.

Patients receiving intravenous lidocaine had significantly reduced opioid consumption and a lower incidence of postoperative nausea and vomiting (PONV) compared to those receiving thoracic epidural anesthesia, suggesting it may be a safer and more effective analgesic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine infusion compared to thoracic epidural analgesia in cytoreductive surgery with or without heated intraperitoneal chemotherapy. A retrospective case-cohort study. Tejedor, A., Bijelic, L., Polanco, M., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Intravenous Lidocaine as an Adjuvant for Pain Associated with Sickle Cell Disease. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Lidocaine and Ketamine Infusions as Adjunctive Pain Management Therapy: A Retrospective Analysis of Clinical Outcomes in Hospitalized Patients Admitted for Pain Related to Sickle Cell Disease. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Perioperative Use of Intravenous Lidocaine. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The analgesic response to intravenous lidocaine in the treatment of neuropathic pain. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of magnesium on length of stay for pediatric sickle cell pain crisis. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine infusion compared to thoracic epidural analgesia in cytoreductive surgery with or without heated intraperitoneal chemotherapy. A retrospective case-cohort study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Intra-Venous Lidocaine to Relieve Neuropathic Pain: A Systematic Review and Meta-Analysis. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of lidocaine infusion during experimental endotoxemia in horses. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Warm lidocaine/tetracaine patch versus placebo before pediatric intravenous cannulation: a randomized controlled trial. [2013]