Clinical trial • Not applicable • Haematology

Lidocaine hydrochloride for Sickle cell anaemia | Vaso-occlusive crisis

Not applicable trial of Lidocaine hydrochloride for Sickle cell anaemia | Vaso-occlusive crisis.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Sickle cell anaemia | Vaso-occlusive crisis
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
21-10-2025
First CTIS Authorization Date
26-01-2026

Trial design

Randomised, morphine pca - standard of care (morphine hydrochloride); dose and schedule not specified in the record.-controlled Not applicable trial across 1 site in Belgium.

Randomised
Yes
Comparator
Morphine PCA - Standard of care (Morphine hydrochloride); dose and schedule not specified in the record.
Target Sample Size
40

Eligibility

Recruits 40 No vulnerable population selected; informed consent obtained from adult participants (see subject information and informed consent form documents listed - K 60 documents)..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
No vulnerable population selected; informed consent obtained from adult participants (see subject information and informed consent form documents listed - K 60 documents).

Inclusion criteria

  • {"criterion_text":"- Vaso - occlusive crisis needing morphine PCA\n- Age 18 or older"}

Exclusion criteria

  • {"criterion_text":"- Age under 18\n- Pregnancy\n- Allergy or adverse reaction to morphine or lidocaine\n- Patient's refusal"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Reduction in morphine consumption","definition_or_measurement_approach":"Primary outcome: a decrease in overall morphine consumption in the intervention group (as stated in the main objective)."}

Secondary endpoints

  • {"endpoint_text":"- Evolution of biomarkers","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Evolution of pain scores using the VAS score","definition_or_measurement_approach":"Measured using the Visual Analogue Scale (VAS) score."}
  • {"endpoint_text":"- Occurence of morphine-related adverse effects","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
40
Recruitment Window Months
17
Consent Approach
Informed consent obtained from adult participants (age 18 or older). Subject information and informed consent forms available (documents K 60 in English, French, Dutch and templates listed). No assent documents noted (minors excluded).

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Belgium

Earliest CTIS Part Ii Submission Date
08-12-2025
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
49
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
CHU Saint Pierre
Department Name
Anesthesiology
Principal Investigator Name
Andrea Carini
Principal Investigator Email
andrea.carini@stpierre-bru.be
Contact Person Name
Andrea Carini
Contact Person Email
andrea.carini@stpierre-bru.be
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
CHU Saint Pierre
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Belgium

Third parties

  • {"country":"","full_name":"Association Vésale","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
LIDOCAINE HYDROCHLORIDE
Active Substance
Lidocaine hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS USE
Route
INTRAVENOUS BOLUS USE
Authorisation Status
SmPC available
Maximum Dose
1080 mg (max daily dose)
Investigational Product Name
MORPHINE HYDROCHLORIDE
Active Substance
Morphine hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS USE
Route
INTRAVENOUS BOLUS USE
Authorisation Status
SmPC available
Maximum Dose
216 mg (max daily dose)
Combination Treatment
Yes

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