Health Trials

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

ConditionVaso-Occlusive Pain Episode in Sickle Cell Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years

Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype

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.

Disqualifiers

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

Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

  • Standard of care

    Drug

    Standard of care

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Experimental group: Lidocaine + standard of careExperimental treatment 2 interventions
Group B: Control group: placebo + standard of carePlacebo comparator 2 interventions

Trial outcomes

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)

Time frame
up to 28 days

Secondary outcomes

1

Intensive Care Unit length of stay

Time frame
up to 28 days
2

hospital length of stay

Time frame
up to 28 days
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nantes University Hospital

Lead sponsor

Source ClinicalTrials.gov
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