Clinical trial • Phase IV • Other
LIDOCAINE HYDROCHLORIDE MONOHYDRATE for Subarachnoid hemorrhage
Phase IV trial of LIDOCAINE HYDROCHLORIDE MONOHYDRATE for Subarachnoid hemorrhage.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Subarachnoid hemorrhage
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-08-2024
- First CTIS Authorization Date
- 26-11-2024
Trial design
Comparators listed: MORPHINE (CHLORHYDRATE) AGUETTANT 10 mg/mL, solution injectable (comparator; max daily dose 20 mg, max total 140 mg); Paracetamol 10mg/ml solution for infusion (comparator; max daily dose 4 g, max total 20 g); NEFOPAM PANPHARMA 20 mg/2 mL, solution injectable/infusion (comparator; max daily dose 100 mg, max total 700 mg). Specific administration schedule for comparators not specified in the record.-controlled Phase IV trial across 1 site in France.
- Comparator
- Comparators listed: MORPHINE (CHLORHYDRATE) AGUETTANT 10 mg/mL, solution injectable (comparator; max daily dose 20 mg, max total 140 mg); Paracetamol 10mg/ml solution for infusion (comparator; max daily dose 4 g, max total 20 g); NEFOPAM PANPHARMA 20 mg/2 mL, solution injectable/infusion (comparator; max daily dose 100 mg, max total 700 mg). Specific administration schedule for comparators not specified in the record.
- Target Sample Size
- 70
- Trial Duration For Participant
- 28
Eligibility
Recruits 70 Vulnerable populations are not selected (isVulnerablePopulationSelected: false). Persons referred to in articles L1121-5 to L1121-8 of the CSP and articles 31 to 35 of Regulation 536/2014 are explicitly excluded. No specific consent/assent procedures for vulnerable populations are described..
- Vulnerable Population
- Vulnerable populations are not selected (isVulnerablePopulationSelected: false). Persons referred to in articles L1121-5 to L1121-8 of the CSP and articles 31 to 35 of Regulation 536/2014 are explicitly excluded. No specific consent/assent procedures for vulnerable populations are described.
Inclusion criteria
- {"criterion_text":"-\t≥ 18 years"}
- {"criterion_text":"- Non-traumatic SAH with or without aneurysm on brain imaging"}
- {"criterion_text":"- WFNS 1 and 2 scores"}
- {"criterion_text":"- Patient awake and extubated after radiological procedure"}
- {"criterion_text":"- Painful patient (EN > 3/10) despite usual level 1 analgesics (Paracetamol + Acupan)"}
- {"criterion_text":"- Affiliated with or benefiting from a social security scheme"}
Exclusion criteria
- {"criterion_text":"- Contraindication to sphenopalatine block (deviated nasal septum, repeated epistaxis, allergy to Lidocaine)"}
- {"criterion_text":"- Patient unable to assess pain by EN"}
- {"criterion_text":"- Persons referred to in articles L1121-5 to L1121-8 of the CSP and articles 31 to 35 of Regulation 536/2014"}
- {"criterion_text":"- Participation in other interventional research"}
- {"criterion_text":"- Patient refusal to participate"}
- {"criterion_text":"- Arteriography more than 48 hours old"}
- {"criterion_text":"- Inaugural headache lasting more than 48 hours"}
- {"criterion_text":"- Presence of an unsecured vascular malformation at high risk of rupture"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Total morphine consumption in mg for the first 72 hours after cerebral arteriography in the ICU.","definition_or_measurement_approach":"Measured as total mg of morphine consumed during the first 72 hours after cerebral arteriography in the ICU."}
Secondary endpoints
- {"endpoint_text":"- 1.\tEN: (Simple Numerical Scale) 7-day average","definition_or_measurement_approach":"Average score on the Simple Numerical Scale (EN) over 7 days after arteriography."}
- {"endpoint_text":"- 2.\tMorphine consumption in mg per day during hospitalization.","definition_or_measurement_approach":"Daily morphine consumption measured in mg during the patient's hospitalization."}
- {"endpoint_text":"- 3.\tComplications of the sphenopalatine block technique: incidence of soft palate anesthesia (false routes to liquids at H+2), epistaxis, vasovagal reactions, transient hearing loss.","definition_or_measurement_approach":"Incidence (number and proportion) of listed complications following sphenopalatine block."}
- {"endpoint_text":"- 4.\tNumber of BGSP failures","definition_or_measurement_approach":"Count of failed BGSP procedures."}
- {"endpoint_text":"- 5.\tEN at D28, consumption of stage 3 analgesics or neuropathic painkillers.","definition_or_measurement_approach":"EN score at day 28 and concomitant use of strong (stage 3) analgesics or neuropathic pain medications."}
- {"endpoint_text":"- 6.\tOverall pain management satisfaction questionnaire","definition_or_measurement_approach":"Patient-reported satisfaction measured using the specified satisfaction questionnaire."}
- {"endpoint_text":"- 7.\tSatisfaction questionnaire for nurses","definition_or_measurement_approach":"Nurse-reported satisfaction measured using the specified nurse questionnaire."}
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 53
- Consent Approach
- Informed consent is obtained from participants (trial includes adults ≥18 years). Subject information and informed consent forms are listed in the documents (L2_SIS and ICF_patient, versions present). No assent procedures or detailed multi-language consent handling are described in the available record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 70
France
- Earliest CTIS Part Ii Submission Date
- 12-11-2024
- Latest Decision Or Authorization Date
- 26-11-2024
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 70
Sites
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Felix PELEN
- Principal Investigator Email
- fpelen@chu-grenoble.fr
- Contact Person Name
- Felix PELEN
- Contact Person Email
- fpelen@chu-grenoble.fr
- Number Of Participants
- 70
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- LIDOCAINE AGUETTANT 20 mg/mL SANS CONSERVATEUR, solution injectable
- Active Substance
- LIDOCAINE HYDROCHLORIDE MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- INTRANASAL USE
- Route
- Intranasal
- Authorisation Status
- Authorised
- Maximum Dose
- 18 ml (maxDailyDoseAmount)
- Investigational Product Name
- LIDOCAÏNE KABI 20 mg/mL, solution injectable
- Active Substance
- LIDOCAINE HYDROCHLORIDE MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- INTRANASAL USE
- Route
- Intranasal
- Authorisation Status
- Authorised
- Maximum Dose
- 18 ml (maxDailyDoseAmount)
- Investigational Product Name
- MORPHINE (CHLORHYDRATE) AGUETTANT 10 mg/mL, solution injectable
- Active Substance
- MORPHINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- Injection
- Authorisation Status
- Authorised
- Maximum Dose
- 20 mg (maxDailyDoseAmount)
- Investigational Product Name
- Paracetamol 10mg/ml solution for infusion
- Active Substance
- PARACETAMOL
- Modality
- Small molecule
- Routes Of Administration
- ORAL AND IV
- Route
- Oral/IV
- Authorisation Status
- Authorised
- Maximum Dose
- 4 g (maxDailyDoseAmount)
- Investigational Product Name
- NEFOPAM PANPHARMA 20 mg/2 mL, solution injectable/pour perfusion
- Active Substance
- NEFOPAM HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL AND IV
- Route
- Oral/IV
- Authorisation Status
- Authorised
- Maximum Dose
- 100 mg (maxDailyDoseAmount)
- Investigational Product Name
- XYLOCAINE VISQUEUSE 2 %, gel oral
- Active Substance
- LIDOCAINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRANASAL USE
- Route
- Intranasal/Oral gel
- Authorisation Status
- Authorised
- Maximum Dose
- 40 mg (maxDailyDoseAmount)
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