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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaso-Occlusive Pain Episode in Sickle Cell Disease
• Intervention / Treatment: Drug: Standard of care; Drug: Lidocain; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Maïté AGBAKOU; Phone Number: +33 02.44.76.80.54; Email: maite.agbakou@chu-nantes.fr

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux
    • Contact: Arthur ORIEUX; Phone Number: +33 05.56.79.56.79; Email: arthur.orieux@chu-bordeaux.fr
  • Lille, France
    • CHU Lille
    • Contact: Arthur DURAND; Phone Number: +33 03.20.44.40.84; Email: arthur.durand@chu-lille.fr
  • Marseille, France
    • CHU La Timone
  • Nantes, France
    • CHU de Nantes
    • Contact: Maïté AGBAKOU; Phone Number: +33 02.40.76.80.54; Email: maite.agbakou@chu-nantes.fr
  • Orléans, France
    • CHU Orléans
    • Contact: Marie SKARZYNSKI; Phone Number: +33 02.38.51.44.46; Email: Marie.skarzynski@chu-orleans.fr
  • Paris, France
    • Hôpital Tenon APHP
    • Contact: Muriel FARTOUKH; Phone Number: +33 01.56.01.61.32; Email: muriel.fartoukh@aphp.fr
  • Poitiers, France
    • CHU Poitiers
    • Contact: Delphine CHATELLIER; Phone Number: +33 05.49.44.43.67; Email: delphine.chatellier@chu-poitiers.fr
  • Rouen, France
    • CHU Rouen
    • Contact: Maximilien GRALL; Phone Number: +33 02.32.88.58.28; Email: maximilien.grall@chu-rouen.fr
  • Toulouse, France
    • Oncopole Toulouse
    • Contact: Sihem BOUHARAOUA; Phone Number: +33 05.31.15.61.14; Email: Bouharaoua.sihem@iuct-oncopole.fr
  • Tours, France
    • CHRU Tours - Hôpital Bretonneau
    • Contact: Charlotte SALMONGANDONNIERE; Phone Number: +33 02.47.47.38.55; Email: c.salmon-gandonniere@chu-tours.fr
• Guadeloupe
  • Les Abymes, Guadeloupe
    • CHU Guadeloupe
    • Contact: Frédéric MARTINO; Phone Number: 05.90.89.11.32; Email: frederic.martino@chu-guadeloupe.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 according to CKD-EPI
• Acute or Chronic kidney failure with clearance <30mL/min/m2
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group: placebo + standard of care; 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: Standard of care; Standard of care; Drug: Placebo; 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.
Experimental: Experimental group: Lidocaine + standard of care; 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: Standard of care; Standard of care; Drug: Lidocain; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care Unit length of stay		up to 28 days
hospital length of stay		up to 28 days
Categorical Pain Score during Intensive Care Unit stay	Compare between groups the pain intensity as evaluated using Categorical Pain Score (CPS)	up to 28 days
Time of resolution of severe vaso-occlusive crisis	presence of at least three of the following four criteria: continuous apyrexia for the last 8 hours,; no need for intravenous opioid infusion for the last 8 hours,; ability to walk or move without pain,; absence of spontaneous pain with a CPS ≤1	up to 28 days
time to last parenteral opioid dose	Time from randomisation to the last parenteral opioid dose	up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay	secondary acute chest syndrome	up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay	need for blood transfusion	up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay	need for red blood cell exchange	up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay	need for life-supporting therapies defined as invasive mechanical ventilation or dialysis or vasopressor support	up to 28 days
safety profile of lidocaine infusion	Compare between groups safety profile of lidocaine infusion at D28	at 28 days
Rate of readmission for vaso-occlusive crisis after Intensive Care Unit discharge	Frequency of any adverse events and frequency of serious adverse events	At day 28
Assess the economic efficiency of lidocaine added to standard of care compared to standard of care alone	Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY) comparing lidocaine + standard of care (SOC) to SOC alone	At day 28
Visual analogue pain Scale score during Intensive Care Unit stay	Compare between groups the pain intensity as evaluated using a Visual Analogue pain Scale from 0 (no pain) to 10 (very intense pain).	up to 28 days
quality of life with reduced impact of Sickle Cell Disease on health	Score of French version of Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me). It is a patient-reported outcome measurement system with a 39 items questionnaire, assessing several aspects of SCD impact on general health state. For the present study, the questionnaires regarding emotional impact, pain episodes, pain impact, Social Functionning will be used.	At Day 28

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Estimated): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain management; Lidocaine; Acute Chest Syndrome; Vaso-occlusive crisis; Opioid sparing; Sickle Cell disease; Sickle Cell Syndrome; Painful crisis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, Inborn; Respiratory Tract Diseases; Neurobehavioral Manifestations; Lung Diseases; Respiration Disorders; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Perceptual Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Anemia, Sickle Cell; Agnosia; Acute Chest Syndrome; Vaso-Occlusive Crises; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: RC24_0427

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No