Evaluation of the efficacy of sphenopalatine block in headache in patients with non-traumatic subarachnoid hemorrhage (SAH) after training of neurosurgical intensive care nurses.

2024-514282-19-00 Protocol 38RC23.0226 SATURN Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 30 May 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol 38RC23.0226 SATURN

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 70
Countries 1
Sites 1

subarachnoid hemorrhage

Demonstrate a 50% reduction in morphine consumption with sphenopalatine block during the first 72 hours after cerebral arteriography.

Key facts

Sponsor
Centre Hospitalier Universitaire Grenoble Alpes
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration
30 May 2025 → ongoing
Decision date (initial)
2024-11-26
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
CHUGA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Demonstrate a 50% reduction in morphine consumption with sphenopalatine block during the first 72 hours after cerebral arteriography.

Secondary objectives 7

  1. 1. Show a significant 3-point reduction in pain on the EN averaged over 7 days after arteriography.
  2. 2. Describe morphine consumption per day during the patient's hospitalization for the 2 groups.
  3. 3. Describe the complications associated with sphenopalatine block.
  4. 4. Evaluate the feasibility of the BGSP act performed by Ides
  5. 5. Show that the sphenopalatine block strategy reduces headaches at 28 days.
  6. 6. To show that the sphenopalatine block strategy improves patient satisfaction at D28
  7. 7. Evaluation of nursing practices using the BGSP technique

Conditions and MedDRA coding

subarachnoid hemorrhage

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. - ≥ 18 years
  2. - Non-traumatic SAH with or without aneurysm on brain imaging
  3. - WFNS 1 and 2 scores
  4. - Patient awake and extubated after radiological procedure
  5. - Painful patient (EN > 3/10) despite usual level 1 analgesics (Paracetamol + Acupan)
  6. - Affiliated with or benefiting from a social security scheme

Exclusion criteria 8

  1. - Contraindication to sphenopalatine block (deviated nasal septum, repeated epistaxis, allergy to Lidocaine)
  2. - Patient unable to assess pain by EN
  3. - Persons referred to in articles L1121-5 to L1121-8 of the CSP and articles 31 to 35 of Regulation 536/2014
  4. - Participation in other interventional research
  5. - Patient refusal to participate
  6. - Arteriography more than 48 hours old
  7. - Inaugural headache lasting more than 48 hours
  8. - Presence of an unsecured vascular malformation at high risk of rupture

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Total morphine consumption in mg for the first 72 hours after cerebral arteriography in the ICU.

Secondary endpoints 7

  1. 1. EN: (Simple Numerical Scale) 7-day average
  2. 2. Morphine consumption in mg per day during hospitalization.
  3. 3. Complications of the sphenopalatine block technique: incidence of soft palate anesthesia (false routes to liquids at H+2), epistaxis, vasovagal reactions, transient hearing loss.
  4. 4. Number of BGSP failures
  5. 5. EN at D28, consumption of stage 3 analgesics or neuropathic painkillers.
  6. 6. Overall pain management satisfaction questionnaire
  7. 7. Satisfaction questionnaire for nurses

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

LIDOCAINE AGUETTANT 20 mg/mL SANS CONSERVATEUR, solution injectable

PRD588621 · Product

Active substance
Lidocaine Hydrochloride Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRANASAL USE
Max daily dose
18 ml millilitre(s)
Max total dose
126 ml millilitre(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
N01BB02 — LIDOCAINE
Marketing authorisation
34009 362 726 0 6
MA holder
LABORATOIRE AGUETTANT
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
change of administration route

LIDOCAÏNE KABI 20 mg/mL, solution injectable

PRD6693931 · Product

Active substance
Lidocaine Hydrochloride Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRANASAL USE
Max daily dose
18 ml millilitre(s)
Max total dose
126 ml millilitre(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
N01BB02 — LIDOCAINE
Marketing authorisation
34009 550 568 8 1
MA holder
FRESENIUS KABI FRANCE S.A.S.
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
change of administration route

Comparator 3

NEFOPAM PANPHARMA 20 mg/2 mL, solution injectable/pour perfusion

PRD10235086 · Product

Active substance
Nefopam Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
ORAL AND IV
Max daily dose
100 mg milligram(s)
Max total dose
700 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
N02BG06 — NEFOPAM
Marketing authorisation
34009 302 686 5 0
MA holder
PANPHARMA
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paracetamol 10mg/ml solution for infusion

PRD607792 · Product

Active substance
Paracetamol
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
ORAL AND IV
Max daily dose
4 g gram(s)
Max total dose
20 g gram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
N02BE01 — PARACETAMOL
Marketing authorisation
PA0736/035/001
MA holder
B.BRAUN MELSUNGEN AG
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MORPHINE (CHLORHYDRATE) AGUETTANT 10 mg/mL, solution injectable

PRD586316 · Product

Active substance
Morphine Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
20 mg milligram(s)
Max total dose
140 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
N02AA01 — MORPHINE
Marketing authorisation
34009 369 105 1 5
MA holder
LABORATOIRE AGUETTANT
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 1

XYLOCAINE VISQUEUSE 2 %, gel oral

PRD4875561 · Product

Active substance
Lidocaine Hydrochloride
Pharmaceutical form
ORAL GEL
Route of administration
INTRANASAL USE
Max daily dose
40 mg milligram(s)
Max total dose
280 mg milligram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
N01BB02 — LIDOCAINE
Marketing authorisation
34009 551 645 8 6
MA holder
ASPEN PHARMA TRADING LIMITED
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Grenoble Alpes

16 Total trials 4 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Centre Hospitalier Universitaire Grenoble Alpes
Address
Boulevard De La Chantourne, Cs 10217, La Tronche Cs 10217 La Tronche
City
Grenoble Cedex 9
Postcode
38043
Country
France

Scientific contact point

Organisation
Centre Hospitalier Universitaire Grenoble Alpes
Contact name
PELEN

Public contact point

Organisation
Centre Hospitalier Universitaire Grenoble Alpes
Contact name
PELEN

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 70 1
Rest of world — 0 —

Investigational sites

France

1 site · Ongoing, recruiting
Centre Hospitalier Universitaire Grenoble Alpes
Anesthésie-Réanimation, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2025-05-30 2025-09-09

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-514282-19-00 1.2
Protocol (for publication) D1_Protocol annexe 1_Investigators list_2024-514282-19-00 1
Protocol (for publication) D1_Protocol annexe 2_RCP Lidocaine Aguettant 20mg-ml_2024-514282-19-00 1
Protocol (for publication) D1_Protocol annexe 3_RCP Lidocaine KABiFresinius 20mg-ml_2024-514282-19-00 1
Protocol (for publication) D1_Protocol annexe 4_RCP Xylocaine_2024-514282-19-00 1
Protocol (for publication) D1_Protocol annexe 5_RCP Morphine Aguettant_2024-514282-19-00 1
Protocol (for publication) D1_Protocol annexe 6_Procedure BSP IDE_2024-514282-19-00 1
Protocol (for publication) D1_Protocol annexe 7_Questionnaire J28 Patient_2024-514282-19-00 1
Protocol (for publication) D1_Protocol annexe 8_Questionnaire satisfaction ide_2024-514282-19-00 1
Protocol (for publication) D1_Protocol annexe 9_HAS-Liste des echelles acceptees pour mesurer la douleur_2024-514282-19-00 1
Protocol (for publication) D1_Protocol Page de signature_2024-514282-19-00 1.1
Protocol (for publication) D1_Protocol_Page de signature_2024-514282-19-00 1.2
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.1
Subject information and informed consent form (for publication) L2_SIS and ICF_patient 1
Subject information and informed consent form (for publication) L2_SIS and ICF_patient_clean 1.2
Subject information and informed consent form (for publication) L2_SIS and ICF_patient_TC 1.2
Summary of Product Characteristics (SmPC) (for publication) D1_Protocol annexe 10_RCP Paracetamol_2024-514282-19-00 1.0
Summary of Product Characteristics (SmPC) (for publication) D1_Protocol annexe 11_RCP Nefopam_2024-514282-19-00 1.0
Summary of Product Characteristics (SmPC) (for publication) D1_Protocol annexe 2_RCP Lidocaine Aguettant 20mg-ml_2024-514282-19-00 1
Summary of Product Characteristics (SmPC) (for publication) D1_Protocol annexe 3_RCP Lidocaine KABiFresinius 20mg-ml_2024-514282-19-00 1
Summary of Product Characteristics (SmPC) (for publication) D1_Protocol annexe 5_RCP Morphine Aguettant_2024-514282-19-00 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis 2024-514282-19-00 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-08-22 France Acceptable
2024-10-28
 2024-11-26

Related clinical trials