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

NCT07274254 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-12-26

No results posted yet for this study

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

Interventions

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

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.

DRUG

Standard of care

Standard of care

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-03-01
Completion
2028-04-01

Countries

  • France
  • Guadeloupe

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07274254 on ClinicalTrials.gov