Vaso-Occlusive Pain Episode in Sickle Cell DiseasePhase 3LidoVOCNCT07274254
Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease
A Phase 3 study testing Lidocain in people with Vaso-Occlusive Pain Episode in Sickle Cell Disease, run by Nantes University Hospital at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaso-Occlusive Pain Episode in Sickle Cell Disease
- What is being tested?
- Lidocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 3 Jul 2026to 3 Aug 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
France11 sites, 11 recruiting
- Recruiting
CHU Bordeaux
Bordeaux
Arthur ORIEUX, 05.56.79.56.79 ext. +33, arthur.orieux@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux - Hôpital Saint-André
Bordeaux
Renaud PREVEL, 0562773545, renaud.prevel@chu-bordeaux.fr
- Recruiting
CHU Lille
Lille
Arthur DURAND, 03.20.44.40.84 ext. +33, arthur.durand@chu-lille.fr
- Recruiting
CHU La Timone
Marseille
Jérémy BOURENNE, 04.13.42.95.96 ext. +33, jeremy.bourenne@ap-hm.fr
- Recruiting
CHU de Nantes
Nantes
Maïté AGBAKOU, 02.40.76.80.54 ext. +33, maite.agbakou@chu-nantes.fr
- Recruiting
CHU Orléans
Orléans
Jonathan WONG SO, 02.38.51.44.46 ext. +33, Marie.skarzynski@chu-orleans.fr
- Recruiting
Hôpital Tenon APHP
Paris
Muriel FARTOUKH, 01.56.01.61.32 ext. +33, muriel.fartoukh@aphp.fr
- Recruiting
CHU Poitiers
Poitiers
Delphine CHATELLIER, 05.49.44.43.67 ext. +33, delphine.chatellier@chu-poitiers.fr
- Recruiting
CHU Rouen
Rouen
Maximilien GRALL, 02.32.88.58.28 ext. +33, maximilien.grall@chu-rouen.fr
- Recruiting
Oncopole Toulouse
Toulouse
Sihem BOUHARAOUA, 05.31.15.61.14 ext. +33, Bouharaoua.sihem@iuct-oncopole.fr
- Recruiting
CHRU Tours - Hôpital Bretonneau
Tours
Charlotte SALMONGANDONNIERE, 02.47.47.38.55 ext. +33, c.salmon-gandonniere@chu-tours.fr
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU Guadeloupe
Les Abymes
Frédéric MARTINO, 05.90.89.11.32, frederic.martino@chu-guadeloupe.fr
About this study
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.
- Being tested
- Lidocain, Placebo, Standard of care
- Keywords
- Sickle Cell disease, Sickle Cell Syndrome, Vaso-occlusive crisis, Acute Chest Syndrome, Painful crisis, Pain management, Opioid sparing, Lidocaine
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Acute Chest Syndrome, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocainDrug
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
PlaceboDrug
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 careDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 28 days
Secondary outcomes (14)
Intensive Care Unit length of stay
Measured: up to 28 days
hospital length of stay
Measured: 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).
Measured: 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)
Measured: 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
Measured: up to 28 days
time to last parenteral opioid dose
Time from randomisation to the last parenteral opioid dose
Measured: up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay
secondary acute chest syndrome
Measured: up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay
need for blood transfusion
Measured: up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay
need for red blood cell exchange
Measured: 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
Measured: 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.
Measured: At Day 28
safety profile of lidocaine infusion
Compare between groups safety profile of lidocaine infusion at D28
Measured: 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
Measured: 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
Measured: At day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start3 Jul 2026
- Primary completion3 Aug 2028 (estimated)
- Study completion3 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaso-Occlusive Pain Episode in Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, radomized, Double blinded, Prospective, Superiority
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274254
- Sponsor's protocol ID
- RC24_0427
- Acronym
- LidoVOC
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No