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Recruiting NCT07001189

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

Observational Sickle Cell Sickle Cell Disease Vaso-Occlusive Crises

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sickle Cell, Sickle Cell Disease, Vaso-Occlusive Crises. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Guadeloupe
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Inflammatory process during vaso-occlusive crises [Time frame: Baseline and Day 1]
Secondary outcome measures (3)
  • Quantification of protein levels [Time frame: Baseline and day 1]
  • Quantification of cytokine levels [Time frame: Baseline and day 1]
  • Quantitative and qualitative profil of blood microparticles [Time frame: Baseline and day 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Guadeloupe · 1 center
  • Chu de La Guadeloupe — Pointe-à-Pitre

Identifiers

NCT: NCT07001189 · PAP_RIPH3_2024/02 · 2024-A00950-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗