Lidocaine to Help Spare Opioids During Vaso-occlusive Crises in Sickle Cell Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, interventional trial compares lidocaine plus standard care versus placebo and standard care for adults hospitalized with a vaso-occlusive crisis or acute chest syndrome due to sickle cell disease. Participants are adults with confirmed genotypes SS, SC, Sβ, or Sβ+ who require parenteral opioids and are within 72 hours of initiating them. The study aims to see if lidocaine can lessen cumulative morphine milligram equivalents compared with placebo. Primary data focus on opioid consumption, with safety monitoring as part of standard trial procedures. The trial is sponsored by Nantes University Hospital with sites in Bordeaux and Lille, France.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>= 18 years
* Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype
* Patient admitted to the Intensive Care Unit for Vaso-Occlusive Crisis and/or ACS as the main reason for admission:

  * Vaso-Occlusive Crisis defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or pelvis, not attributable to other causes
  * Acute Chest Syndrome defined by the association of clinical respiratory sign(s): dyspnea and/or chest pain and/or auscultatory abnormality (crepitants and/or bronchial breathing) with a new pulmonary infiltrate on chest X-ray, thoracic CT-scan, or lung ultrasound.
* Treatment with parenteral morphine or oxycodone started less than 72 hours prior to inclusion
* Patient or next of kin informed about the study and having consented to the participation of the patient in the study. If patient is no competent and no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the Intensive Care Unit physician, in compliance with French law.
* French speaking
* Patient with health care insurance

Exclusion Criteria:

* Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
* Patients under guardianship, curatorship or under legal protection
* Prisoners or subjects who are involuntarily incarcerated
* Sickle Cell Disease acute complication other than Vaso-Occlusive Crisis or Acute Chest Syndrome as the main reason for admission:

priapism, stroke, acute splenic sequestration, acute hepatic sequestration, bone marrow necrosis…

* Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion
* Known or assumed hypersensitivity to lidocaine hydrochloride, other local anaesthetics (e.g., bupivacaine or ropivacaine) or an excipient
* Patients treated with anti-arhythmic drugs known to induce torsade de pointe.
* Patients on chronic or occasional treatment with drugs that interact with the 3A cytochrome isoenzymes (CYP3A) and/or 1A2 cytochrome isoenzymes (CYP1A2)
* Patients with recurrent porphyria, porphyria in remission, or known asymptomatic carriage of gene mutations responsible for porphyria
* Epileptic patients
* Hypovolemic shock or shock of other cause at screening for inclusion
* Known atrioventricular block, QT prolongation or other heart conduction disorder or heart failure
* Chronic respiratory failure with long term non invasive ventilation (excluding Continuous Positive Air way pressure), or long term oxygen therapy at home
* Acute Respiratory Distress Syndrome according to The 2012 Berlin definition
* Acute or Chronic liver failure with MELD \> 19
* Acute or Chronic kidney failure with clearance \<30mL/min/m2 according to CKD-EPI
* Body weight \<40kg and \>120kg
* Prior inclusion in the study in the last 3 months
* Patient under invasive mechanical ventilation
* Altered consciousness with Glasgow coma scale \<13
* Patient already included in a clinical drug

Where it's running

• CHU Bordeaux
  Bordeaux, France Recruiting
• CHU de Bordeaux - Hôpital Saint-André
  Bordeaux, France Recruiting
• CHU Lille
  Lille, France Recruiting
• CHU La Timone
  Marseille, France Recruiting
• CHU de Nantes
  Nantes, France Recruiting
• CHU Orléans
  Orléans, France Recruiting

Study contacts

• Study coordinator: Maïté AGBAKOU
• Email: maite.agbakou@chu-nantes.fr
• Phone: 02.44.76.80.54

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-dose ketamine for sickle cell vaso-occlusive pain in children and young adults

  This trial will test whether adding a low (sub-dissociative) dose ketamine infusion to usual IV opioid pain medicine helps children and young adults (ages 5–20) with sickle cell disease have better pain relief and remain safe during a vaso-occlusive episode.

  Recruiting Phase 2 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Torrance, California · NCT07369024

• Depo-Provera (depot medroxyprogesterone acetate) for pain and biomarker changes in women with sickle cell disease

  This study will test whether an injectable birth control (Depo-Provera) can reduce pain in adult women with sickle cell disease.

  Recruiting Phase 4 University of Pennsylvania · Atlanta, Georgia and 1 other locations · NCT06665997

• Using virtual reality to help manage pain in sickle cell disease patients

  This study is testing if using virtual reality can help adults with sickle cell disease feel less pain during painful episodes.

  Recruiting University of Maryland, Baltimore · Baltimore, Maryland · NCT06184126

• Evaluating CSL889 for treating vaso-occlusive crises in sickle cell disease

  This study is testing a new treatment called CSL889 to see if it can help adults and teens with sickle cell disease who are having painful vaso-occlusive crises feel better.

  Recruiting at 28 sites Phase 2 CSL Behring · Oakland, California and 29 other locations · NCT06699849

• Using intravenous L-citrulline to treat pain in sickle cell disease

  This study is testing if giving L-citrulline through an IV can help kids and young adults with sickle cell disease feel better faster during painful episodes.

  Recruiting Phase 2 Children's National Research Institute · Washington D.C., District of Columbia · NCT06635902

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.