Sickle CellALRCVO-MPNCT07001189
Impact of Regional Anesthesia on Inflammatory Mechanisms During Vaso-occlusive Crisis in Sickle Cell Patients
An observational study of Sickle Cell and Sickle Cell Disease, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell, Sickle Cell Disease, Vaso-Occlusive Crises
- How many people
- 34 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 5 Feb 2025to 5 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult sickle cell patients consulting for vaso-occlusive crisis in CHU de Guadeloupe
Who may be able to join
- patients adult >18 years
- patients with vaso-occlusive crisis
Who cannot join
- Pregnant or breastfeeding women
- Blood transfusion within the last 3 months
- Lack of affiliation with the French social security system
- Protected individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe1 site, 1 recruiting
- Recruiting
Chu de La Guadeloupe
Pointe-à-Pitre, 97159
Mélanie petapermal, +590590934667, melanie.petapermal@chu-guadeloupe.fr
Amelie Rolle, MD
About this study
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.
- Conditions
- Sickle Cell, Sickle Cell Disease, Vaso-Occlusive Crises
- Keywords
- Loco-regional anesthesia, inflammation, Vaso-Occlusive Crises
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 1
Secondary outcomes (3)
Quantification of protein levels
ICAM-1, VCAM-1, P-selectin, Elastase (marker of neutrophil extracellular traps (NET)
Measured: Baseline and day 1
Quantification of cytokine levels
Quantification of cytokine levels
Measured: Baseline and day 1
Quantitative and qualitative profil of blood microparticles
Quantitative and qualitative profil of blood microparticles
Measured: Baseline and day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start5 Feb 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amelie Rolle, MD, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001189
- Sponsor's protocol ID
- PAP_RIPH3_2024/02
- Other IDs
- 2024-A00950-47
- Acronym
- ALRCVO-MP
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regional Anesthesia on Inflammatory Mechanisms During Vaso-occlusive Crisis in Sickle Cell Patients
- ClinicalTrials.gov ID
- NCT07001189
- Acronym / sponsor ID
- ALRCVO-MP / PAP_RIPH3_2024/02
- Conditions
- Sickle Cell, Sickle Cell Disease, Vaso-Occlusive Crises
- Keywords
- Loco-regional anesthesia, inflammation, Vaso-Occlusive Crises
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult sickle cell patients consulting for vaso-occlusive crisis in CHU de Guadeloupe
Key inclusion criteria (2 listed)
- patients adult >18 years
- patients with vaso-occlusive crisis
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- Blood transfusion within the last 3 months
- Lack of affiliation with the French social security system
- Protected individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amelie Rolle, MD principal investigator
CHU de la Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell and Sickle Cell Disease, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie Hamony Soter (+590590934677, valerie.soter@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory process during vaso-occlusive crises (time frame: Baseline and Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.