NCT07274254

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2025-12-10
• Last updated: 2025-12-26

Locations

11 sites across 2 countries: France, Guadeloupe