ClinicalTrials.gg
RecruitingNCT07001189ALRCVO-MPUpdated Jun 3, 2025

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

An observational study in Sickle Cell, Sickle Cell Disease and Vaso-Occlusive Crises, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 1 site in Guadeloupe. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-03.

Primary conditionVaso-Occlusive CrisesRegistry: Anemia, Sickle CellReclassifiedWhy we changed it
Registry
Anemia, Sickle Cell — the first condition term the registry derived for this study.
ClinicalTrials.gg
Vaso-Occlusive Crises
Why
  1. The study's listed conditions name Vaso-Occlusive Crises, a narrower term within Anemia, Sickle Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sickle Cell
  • Sickle Cell Disease
  • Vaso-Occlusive Crises

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Keywords

  • Loco-regional anesthesia
  • inflammation
  • Vaso-Occlusive Crises
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In context

Vaso-Occlusive Crises Reclassified

104 studies on the registry are indexed under Vaso-Occlusive Crises; 31 are open to participants now.

This study's planned enrollment of 34 is below the median of 98 across 13 observational studies indexed under Vaso-Occlusive Crises.

Browse Vaso-Occlusive Crises studies →

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.

Compared within Vaso-Occlusive Crises, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia, Sickle Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Blood transfusion within the last 3 months
  • Lack of affiliation with the French social security system
  • Protected individuals
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
34 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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).

06

What researchers measure

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.

    Time frame: Baseline and Day 1

Secondary outcomes

  1. Quantification of protein levels

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

    Time frame: Baseline and day 1

  2. Quantification of cytokine levels

    Quantification of cytokine levels

    Time frame: Baseline and day 1

  3. Quantitative and qualitative profil of blood microparticles

    Quantitative and qualitative profil of blood microparticles

    Time frame: Baseline and day 1

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2025 (actual). Primary completion is estimated for Feb 2027, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2025
First posted
Jun 3, 2025
StartActual
Feb 5, 2025
Primary completionEst.
Feb 5, 2027
CompletionEst.
Feb 5, 2027
Last update
Jun 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07001189
Lead sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Responsible party
Sponsor
First posted
Jun 3, 2025
Start date
Feb 5, 2025
Primary completion
Feb 5, 2027 (estimated)
Completion
Feb 5, 2027 (estimated)
Last update
Jun 3, 2025

Study contacts

Valérie Hamony Soter
Contact
valerie.soter@chu-guadeloupe.fr
+590590934677
Mélanie Petapermal
Contact
melanie.petapermal@chu-guadeloupe.fr
+590590934667
Amelie Rolle, MD
principal investigator · CHU de la Guadeloupe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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