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

NCT07274254 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: RC24_0427
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 11

Brief 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.

Conditions

Vaso-Occlusive Pain Episode in Sickle Cell Disease

Keywords

Sickle Cell disease; Sickle Cell Syndrome; Vaso-occlusive crisis; Acute Chest Syndrome; Painful crisis; Pain management; Opioid sparing; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Cumulative parenteral opioid dose between randomization and discharge from the intensive care unit expressed in morphine milligram equivalent.

  To determine whether adding lidocaine to the standard of care in pain during severe vaso-occlusive crisis has an effect on the cumulative opioid consumption expressed as morphine milligram equivalent (MME)

  up to 28 days

Secondary Outcomes (14)

• Intensive Care Unit length of stay

  up to 28 days

• hospital length of stay

  up to 28 days

• Visual analogue pain Scale score during Intensive Care Unit stay

  up to 28 days

• Categorical Pain Score during Intensive Care Unit stay

  up to 28 days

• Time of resolution of severe vaso-occlusive crisis

  up to 28 days

Study Arms (2)

Experimental group: Lidocaine + standard of care

EXPERIMENTAL

Lidocaine hydrochloride 20 mg/mL, solution, 20 mL ampoule for intravenous administration Administration : parenteral route on peripheral or central venous catheter. * Bolus of 1.5 mg/kg bolus during 30 minutes, with a maximum dose of 180 mg (18mL) * Immediately followed by a continuous infusion of 1 mg/kg/h (max 120mg/h =- 12mL/h) during 72 hours.

Drug: Lidocain; Drug: Standard of care

Control group: placebo + standard of care

PLACEBO COMPARATOR

Placebo is 20 mL ampoules of sodium chloride (NaCl 0.9%) for injection. Administration : parenteral route on peripheral or central venous catheter. * Bolus of 1.5 mg/kg bolus during 30 minutes, with a maxium dose of 180 mg (18mL) * Immediately followed by a continuous infusion of 1 mg/kg/h (max 120mg/h = 12mL/h) during 72 hours.

Drug: Placebo; Drug: Standard of care

Interventions

Lidocain DRUG

Lidocaine hydrochloride 20 mg/mL, solution, 20 mL ampoule for IV administration (25 ampoules) Administration : parenteral route on peripheral or central venous catheter. - Bolus of 1.5 mg/kg bolus dur

Experimental group: Lidocaine + standard of care

Placebo DRUG

Placebo is 20 mL ampoules of sodium chloride (NaCl 0.9%) for injection Administration : parenteral route on peripheral or central venous catheter. * Bolus of 1.5 mg/kg bolus during 30 minutes, with a maxium dose of 180 mg (18mL) * Immediately followed by a continuous infusion of 1 mg/kg/h (max 120mg/h = 12mL/h) during 72 hours.

Control group: placebo + standard of care

Standard of care DRUG

Standard of care

Control group: placebo + standard of care; Experimental group: Lidocaine + standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• French speaking
• Patient with health care insurance

You may not qualify if:

• 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…
• 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
• 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 according to CKD-EPI
• Acute or Chronic kidney failure with clearance \<30mL/min/m2
• Body weight \<40kg and \>120kg

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (11)

CHU Bordeaux

Bordeaux, France

Location

CHU Lille

Lille, France

Location

CHU La Timone

Marseille, France

Location

CHU de Nantes

Nantes, France

Location

CHU Orléans

Orléans, France

Location

Hôpital Tenon APHP

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rouen

Rouen, France

Location

Oncopole Toulouse

Toulouse, France

Location

CHRU Tours - Hôpital Bretonneau

Tours, France

Location

CHU Guadeloupe

Les Abymes, Guadeloupe

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Acute Chest Syndrome; Agnosia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Maïté AGBAKOU

CONTACT

02.44.76.80.54; maite.agbakou@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled, radomized, Double blinded, Prospective, Superiority

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 10, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (10); GU (1)