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IV Lidocaine for Sickle Cell Crisis (RELIEF-SCC Trial)

Phase 2

Waitlist Available

Led By Shreni Zinzuwadia, MD

Research Sponsored by Community Medical Center, Toms River, NJ

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 and 90 minutes

Awards & highlights

RELIEF-SCC Trial Summary

This trial is testing whether giving IV lidocaine to people with sickle cell disease in addition to opioids will reduce pain and the overall amount of opioids needed.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Lidocaine may cause side effects such as dizziness, numbness around the mouth, tingling sensations, low blood pressure, irregular heartbeats, sleepiness or confusion.

RELIEF-SCC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

RELIEF-SCC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 and 90 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 and 90 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 and 90 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in pain at 30 minutes

Secondary outcome measures

% Patients requiring additional opiate administration

Change in visual analog pain scale (VAS, 0-10 with 10 being the most pain) at 60 and 90 minutes

Number of adverse effects of treatment

+5 more

RELIEF-SCC Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: LidocaineActive Control1 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: PlaceboPlacebo Group1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers Robert Wood Johnson Medical SchoolOTHER

4 Previous Clinical Trials

11,162 Total Patients Enrolled

Community Medical Center, Toms River, NJLead Sponsor

4 Previous Clinical Trials

1,055 Total Patients Enrolled

Newark Beth Israel Medical CenterOTHER

11 Previous Clinical Trials

1,199 Total Patients Enrolled

Media Library

Lidocaine Clinical Trial Eligibility Overview. Trial Name: NCT04614610 — Phase 2

Acute Pain Research Study Groups: Lidocaine, Placebo

Acute Pain Clinical Trial 2023: Lidocaine Highlights & Side Effects. Trial Name: NCT04614610 — Phase 2

Lidocaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04614610 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any previous experiments explored the medical use of Lidocaine?

"Currently, 118 clinical studies are investigating lidocaine and 31 of them have advanced to Phase 3. These research endeavours can be found in 1094 centres globally with a majority located in Calgary, Alberta."

Answered by AI

How many individuals are enrolled in the ongoing clinical trial?

"Unfortunately, this research endeavour has concluded its recruitment phase. It was first posted on 10th October 2022 and last updated 18th July 2022. Fortunately, there are still 516 trials related to pain-management that require participants, while 118 studies concerning lidocaine are actively seeking enrolment."

Answered by AI

Are there still participants being accepted into this experiment?

"Unfortunately, the recruitment phase for this clinical trial has already concluded. It was initially posted on October 1st 2022 and last modified on July 18th of the same year. There are currently 516 studies seeking participants with pain and 118 trials requiring Lidocaine volunteers if you are interested in considering alternative opportunities."

Answered by AI

For what maladies has Lidocaine been found to be an effective remedy?

"Lidocaine is often administered to treat cervical syndrome, as well as minor burns, transplantation procedures, and osteoporosis."

Answered by AI

To what degree can patients rely on Lidocaine's safety?

"After careful consideration, our team at Power concluded that Lidocaine has a safety rating of 2 out of 3. This is because there is evidence to suggest its safe usage but no proof yet for efficacy."

Answered by AI

To what extent are hospitals in this city administering the research project?

"This trial is presently enrolling participants through 4 medical centres. These sites are situated in Long Branch, Newark, New Brunswick and other proximal regions. Those wishing to take part should select the closest centre as a means of reducing their travel requirements."

Answered by AI

Recent research and studies

Annals of Emergency MedicineJournal

Safety and Efficacy of Intravenous Lidocaine for Pain Management in the Emergency Department: A Systematic Review

e Silva, Lucas Oliveira J., Kristin Scherber, Daniel Cabrera, Sergey Motov, Patricia J. Erwin, Colin P. West, M. Hassan Murad, and M. Fernanda Bellolio. 2018. “Safety and Efficacy of Intravenous Lidocaine for Pain Management in the Emergency Department: A Systematic Review”. Annals of Emergency Medicine. Elsevier BV. doi:10.1016/j.annemergmed.2017.12.014.

Pediatric Blood & CancerJournal

Impact of Early Analgesia on Hospitalization Outcomes for Sickle Cell Pain Crisis

Payne, Jason, Inmaculada Aban, Lee M. Hilliard, Jennifer Madison, Christina Bemrich-Stolz, Thomas H. Howard, Amanda Brandow, Emily Waite, and Jeffrey D. Lebensburger. 2018. “Impact of Early Analgesia on Hospitalization Outcomes for Sickle Cell Pain Crisis”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.27420.

Academic Emergency MedicineJournal

Validation of a Verbally Administered Numerical Rating Scale of Acute Pain for Use in the Emergency Department

Bijur, Polly E., Clarke T. Latimer, and E. John Gallagher. 2003. “Validation of a Verbally Administered Numerical Rating Scale of Acute Pain for Use in the Emergency Department”. Academic Emergency Medicine. Wiley. doi:10.1111/j.1553-2712.2003.tb01355.x.

The American Journal of Emergency MedicineJournal