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

NCT07001189 | Recruiting

• 2 other identifiers: PAP_RIPH3_2024/022024-A00950-47
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell; Sickle Cell Disease; Vaso-Occlusive Crises

Keywords

Loco-regional anesthesia; inflammation; Vaso-Occlusive Crises

Outcome Measures

Primary Outcomes (1)

• Inflammatory process during vaso-occlusive crises

  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.

  Baseline and Day 1

Secondary Outcomes (3)

• Quantification of protein levels

  Baseline and day 1

• Quantification of cytokine levels

  Baseline and day 1

• Quantitative and qualitative profil of blood microparticles

  Baseline and day 1

Study Arms (2)

RA-Group

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

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult sickle cell patients consulting for vaso-occlusive crisis in CHU de Guadeloupe

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Chu de La Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of two blood tubes for the quantification of protein and cytokine levels, and for the quantitative and qualitative analysis of circulating blood microparticles.

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Inflammation

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amelie Rolle, MD

  CHU de la Guadeloupe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Hamony Soter

CONTACT

+590590934677; valerie.soter@chu-guadeloupe.fr

Mélanie Petapermal

CONTACT

+590590934667; melanie.petapermal@chu-guadeloupe.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

GU (1)