Clinical trial NCT07001189: Impact of Regional Anesthesia on Inflammatory Mechanisms During Vaso-occlusive Crisis in Sickle Cell Patients
Official title: Impact of Regional Anesthesia on Inflammatory Mechanisms During Vaso-occlusive Crisis in Sickle Cell Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sickle Cell
Sickle Cell Disease
Vaso-Occlusive Crises
Keywords: Loco-regional anesthesia
inflammation
Vaso-Occlusive Crises
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult sickle cell patients consulting for vaso-occlusive crisis in CHU de 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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory process during vaso-occlusive crises
timeFrame: Baseline and Day 1
Secondary outcomes:
measure: Quantification of protein levels
timeFrame: Baseline and day 1
measure: Quantification of cytokine levels
timeFrame: Baseline and day 1
measure: Quantitative and qualitative profil of blood microparticles
timeFrame: Baseline and day 1
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: Guadeloupe
facility: Chu de La Guadeloupe
Study officials:
affiliation: CHU de la Guadeloupe
name: Amelie Rolle, MD
role: PRINCIPAL_INVESTIGATOR
References: