IV Lidocaine for Sickle Cell Crisis

(RELIEF-SCC Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether IV lidocaine, a pain relief medication, can reduce the need for opioids in individuals experiencing a sickle cell crisis. Sickle cell crisis causes severe pain, and while opioids are the usual treatment, they can lead to other issues. By adding IV lidocaine to the treatment plan, the study aims to determine if it can effectively relieve pain and decrease opioid use. Individuals with sickle cell disease who are currently experiencing severe pain, even after receiving opioids, might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IV lidocaine can safely and effectively complement opioid treatments for managing pain during sickle cell crises. Studies have found it to be generally well-tolerated for this purpose. For instance, one study found that IV lidocaine was safe and improved pain management for patients experiencing painful blockages of blood flow. Another source highlights that incorporating IV lidocaine into a treatment plan was both safe and effective for better pain control.

Some reports mention longer hospital stays for patients receiving IV lidocaine, but this may result from other factors, such as the complexity of their condition, rather than the treatment itself. Overall, the available evidence suggests that IV lidocaine is a promising option for managing pain in sickle cell crises. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sickle cell crisis?

Most treatments for sickle cell crisis focus on managing pain with opioids like morphine or hydromorphone. However, this new approach adds IV lidocaine, typically used as a local anesthetic, to potentially provide rapid pain relief. Researchers are excited because lidocaine might work differently by directly affecting nerve signals, potentially reducing the need for high doses of opioids. This could lead to fewer side effects and a faster, more effective way to manage a sickle cell crisis.

What evidence suggests that IV lidocaine could be an effective treatment for sickle cell crisis?

Research has shown that IV lidocaine, which participants in this trial may receive, can help manage pain during a sickle cell crisis. Studies have found that using IV lidocaine with opioids reduces the amount of opioids needed for pain relief. This reduction is crucial in light of the current opioid crisis, as it means less dependence on opioids. Specifically, one study found that patients experienced less pain and used fewer opioids when IV lidocaine was part of their treatment. Additionally, IV lidocaine has proven to be safe and well-tolerated by patients. These findings suggest that IV lidocaine could effectively manage sickle cell pain. ^{1 2 5 6 7}

Who Is on the Research Team?

Shreni Zinzuwadia, MD

Principal Investigator

Newark Beth Israel

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26654408/

Intravenous Lidocaine as an Adjuvant for Pain Associated ... The authors conclude that adjuvant IV lidocaine provided pain relief and a mean reduction in MDE during sickle cell pain crisis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04614610?term=AREA%5BBasicSearch%5D(Hemoglobinopathy%20Toms%20River)&rank=1

Lidocaine Intravenous in the Emergency Department For ... 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 ...

3. ashpublications.org ashpublications.org/blood/article/138/Supplement%201/2962/478929/Implementation-of-an-Intravenous-Lidocaine

Implementation of an Intravenous Lidocaine Guideline for ... This retrospective cohort study reviewed records of children with SCD age ≥10 years admitted for VOE at SLCH during 2018-2020. Data collected ...

4. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2022.878985/full

Lidocaine and Ketamine Infusions as Adjunctive Pain ... Conclusion: Both ketamine and lidocaine infusion therapies are effective in reducing opioid consumption for patients with vaso-occlusive crisis.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0006497121048990

Implementation of an Intravenous Lidocaine Guideline for ... In our cohort, IV lidocaine was safe, tolerable, and improved pain control. The care guideline was initiated within 24 hours for 78.7% of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39663785/

Safety and Tolerability of Intravenous Lidocaine Infusions ... Lidocaine infusions were associated with longer hospitalizations, potentially reflecting selection bias. The efficacy of adjuvant lidocaine infusions during VOE ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pbc.31458

Safety and Tolerability of Intravenous Lidocaine Infusions ... Safety and Tolerability of Intravenous Lidocaine Infusions as Opioid Adjunct for Children Hospitalized With Sickle Cell Vaso-Occlusive Pain.