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NCT Number: NCT07001189

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de La Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

Location status: Recruiting

Location contact

Amelie Rolle, MD

PRINCIPAL_INVESTIGATOR

Mélanie petapermal

CONTACT

[email protected]

+590590934667

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Inflammatory process during vaso-occlusive crises

    Time frame: 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 outcomes

  1. Quantification of protein levels

    Time frame: Baseline and day 1

    ICAM-1, VCAM-1, P-selectin, Elastase (marker of neutrophil extracellular traps (NET)

  2. Quantification of cytokine levels

    Time frame: Baseline and day 1

    Quantification of cytokine levels

  3. Quantitative and qualitative profil of blood microparticles

    Time frame: Baseline and day 1

    Quantitative and qualitative profil of blood microparticles

Study contacts

Contact information is provided by the study sponsor or research team.

Mélanie Petapermal

CONTACT

[email protected]

+590590934667

Valérie Hamony Soter

CONTACT

[email protected]

+590590934677

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Other

Registry information

Acronym: ALRCVO-MP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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