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Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease

NCT07274254•Nantes University Hospital

Summary

The purpose of the study is to determine whether adding lidocaine to standard of care in pain management during severe vaso-occlusive crisis has an effect on the cumulative opioid consumption expressed as morphine milligram equivalent.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+11 more criteria

Locations (11)

CHU Bordeaux

Bordeaux, France

CHU Lille

Lille, France

CHU La Timone

Marseille, France

CHU de Nantes

Nantes, France

CHU Orléans

Orléans, France

Hôpital Tenon APHP

Paris, France

CHU Poitiers

Poitiers, France

CHU Rouen

Rouen, France

Oncopole Toulouse

Toulouse, France

CHRU Tours - Hôpital Bretonneau

Tours, France

Key Dates

Start Date

March 1, 2026

Primary Completion Date

March 1, 2028

Completion Date

April 1, 2028

Last Updated

December 26, 2025

Enrollment

104

ESTIMATED participants

Conditions

Vaso-Occlusive Pain Episode in Sickle Cell Disease

Interventions

Lidocain

DRUG

Placebo

DRUG

Standard of care

DRUG

Contacts

Maïté AGBAKOU

CONTACT

02.44.76.80.54 maite.agbakou@chu-nantes.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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