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

C

Centre Hospitalier Universitaire de la Guadeloupe

Status

Enrolling

Conditions

Vaso-Occlusive Crises
Sickle Cell Disease
Sickle Cell

Study type

Observational

Funder types

Other

Identifiers

NCT07001189
PAP_RIPH3_2024/02
2024-A00950-47 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

34 participants in 2 patient groups

RA-Group
Description:
When a sickle cell patient comes to the emergency department with pain such as vaso-occlusive crises, we will offer them the opportunity to participate in the study. Inclusion will therefore occur before the choice of analgesic technique. The patient will receive the treatment they have chosen (with or without regional anesthesia). Depending on their choice and/or any contraindications (e.g., morphine intolerance or allergy to ropivacaine), they will be placed in the "RA group" (if they received regional anesthesia) or the "non-RA group" (if they did not receive it).
Non-RA group
Description:
When a sickle cell patient comes to the emergency department with pain such as vaso-occlusive crises, we will offer them the opportunity to participate in the study. Inclusion will therefore occur before the choice of analgesic technique. The patient will receive the treatment they have chosen (with or without regional anesthesia). Depending on their choice and/or any contraindications (e.g., morphine intolerance or allergy to ropivacaine), they will be placed in the "RA group" (if they received regional anesthesia) or the "non-RA group" (if they did not receive it).

Trial contacts and locations

1

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Central trial contact

Mélanie Petapermal; Valérie Hamony Soter

Data sourced from clinicaltrials.gov

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