Could a common numbing drug cut opioid needs in sickle cell emergencies?
NCT ID NCT07274254
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times
Summary
This study tests whether adding lidocaine, a numbing medicine, to standard pain treatment can lower the amount of strong opioids needed during severe sickle cell pain crises. About 104 adults with sickle cell disease who are in the intensive care unit for a pain crisis will take part. The goal is to see if lidocaine helps control pain while reducing opioid use and side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHRU Tours - Hôpital Bretonneau
RECRUITINGTours, France
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CHU Bordeaux
RECRUITINGBordeaux, France
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CHU Guadeloupe
RECRUITINGLes Abymes, Guadeloupe
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CHU La Timone
RECRUITINGMarseille, France
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CHU Lille
RECRUITINGLille, France
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CHU Orléans
RECRUITINGOrléans, France
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CHU Poitiers
RECRUITINGPoitiers, France
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CHU Rouen
RECRUITINGRouen, France
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CHU de Bordeaux - Hôpital Saint-André
RECRUITINGBordeaux, France
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CHU de Nantes
RECRUITINGNantes, France
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Hôpital Tenon APHP
RECRUITINGParis, France
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Oncopole Toulouse
RECRUITINGToulouse, France
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