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

August 28, 2023 updated by: Andrew Vassallo, Community Medical Center, Toms River, NJ

Randomized Trial Evaluating Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis - RELIEF-SCC

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from pre-lidocaine infusion to 30 minutes post-infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
% 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.
from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
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.
from administration of lidocaine infusion until patient disposition (up to 12 hours) or next opiate administered
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
12 hours post-lidocaine or placebo infusion.
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.
from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
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).
from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
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.
60 and 90 minutes
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
from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Community Medical Center, Toms River, NJ

Collaborators

Monmouth Medical Center
Newark Beth Israel Medical Center
Rutgers Robert Wood Johnson Medical School

Investigators

  • Principal Investigator: Shreni Zinzuwadia, MD, Newark Beth Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 2, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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