A Phase 3 interventional study of Lidocain and Placebo in Vaso-Occlusive Pain Episode in Sickle Cell Disease, sponsored by Nantes University Hospital. Recruiting at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Nantes University Hospital · Phase 3, Interventional, and Treatment
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.
104 studies on the registry are indexed under Vaso-Occlusive Crises; 31 are open to participants now.
This study's planned enrollment of 104 is above the median of 81 across 86 interventional studies indexed under Vaso-Occlusive Crises.
Browse Vaso-Occlusive Crises studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Compared within Vaso-Occlusive Crises, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia, Sickle Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient admitted to the Intensive Care Unit for Vaso-Occlusive Crisis and/or ACS as the main reason for admission:
Exclusion Criteria:
priapism, stroke, acute splenic sequestration, acute hepatic sequestration, bone marrow necrosis…
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
Standard of care
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)
Time frame: up to 28 days
Intensive Care Unit length of stay
Time frame: up to 28 days
hospital length of stay
Time frame: up to 28 days
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).
Time frame: 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)
Time frame: 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
Time frame: up to 28 days
time to last parenteral opioid dose
Time from randomisation to the last parenteral opioid dose
Time frame: up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay
secondary acute chest syndrome
Time frame: up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay
need for blood transfusion
Time frame: up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay
need for red blood cell exchange
Time frame: 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
Time frame: 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.
Time frame: At Day 28
safety profile of lidocaine infusion
Compare between groups safety profile of lidocaine infusion at D28
Time frame: 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
Time frame: 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
Time frame: At day 28
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Studies of the drug tested here: Lidocaine