Impact of Regional Anesthesia on Inflammatory Mechanisms During Vaso-occlusive Crisis in Sickle Cell Patients

Recruiting

• Conditions: Sickle Cell; Sickle Cell Disease; Vaso-Occlusive Crises

• Registration Number: NCT07001189
• Lead Sponsor: Centre Hospitalier Universitaire de la Guadeloupe

Brief Summary

Sickle cell disease is a chronic disease characterized by multiple vaso-occlusive complications. The basic treatment for patients with a vaso-occlusive crisis (VOC) is based on adequate hydration, oxygen therapy and pain control. Loco Regional Anesthesia (LRA) is one of the major treatments in resuscitation anesthesia for both anesthesia and analgesia. LRA allows effective and almost immediate pain control by blocking nerve afferents in a given area. LRA could decrease the inflammatory response during crises and accelerate resolution of the crisis.

Detailed Description

Regional anesthesia (RA) possesses intrinsic anti-inflammatory properties and can modulate the inflammatory response. For instance, ropivacaine reduces inflammation induced in vitro in rat epithelial cells. At the cellular level, lidocaine decreases free radical production by neutrophils, inhibits leukocyte phagocytic activity, and significantly suppresses cytokine production in response to endotoxemia.

The value of RA no longer lies solely in its ability to block nociceptive input via sodium channel inhibition. A peripheral nerve block with local anesthetics inhibits local neurogenic inflammation, thereby reducing sensitization, hyperalgesia, and the risk of pain chronification. A peripheral nerve block is therefore an anti-inflammatory treatment.

However, no study has yet demonstrated the anti-inflammatory effects of RA at the cellular level in sickle cell disease patients.

The aim of this study is to analyze the evolution of inflammatory markers during vaso-occlusive crises (e.g., MPs, cytokines, NETs, etc.), by comparing patients who received RA to those who did not during hospitalization.

Study Timeline

• Study Start: 2025-02-05
• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Primary Completion: 2027-02-05
• Study Completion: 2027-02-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• patients adult >18 years
• patients with vaso-occlusive crisis

Exclusion Criteria

• Pregnant or breastfeeding women
• Blood transfusion within the last 3 months
• Lack of affiliation with the French social security system
• Protected individuals

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory process during vaso-occlusive crises	Baseline and Day 1	The variation between D0 and D1 in the proportion of endothelial cells expressing ICAM-1 on their surface, following stimulation with microparticles from patients who received or did not receive regional anesthesia.

Secondary Outcome Measures

Name	Time	Method
Quantification of protein levels	Baseline and day 1	ICAM-1, VCAM-1, P-selectin, Elastase (marker of neutrophil extracellular traps (NET)
Quantification of cytokine levels	Baseline and day 1	Quantification of cytokine levels
Quantitative and qualitative profil of blood microparticles	Baseline and day 1	Quantitative and qualitative profil of blood microparticles

Trial Locations

Locations (1)

Chu de La Guadeloupe; 🇬🇵 Pointe-à-Pitre, Guadeloupe