Effectiveness of a Nerve Block in the Back of the Head for Treating Headaches Caused by Bleeding in the Brain

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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], Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

11 Jul 2025 → ongoing

Decision date (initial)

2025-05-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To determine the efficacy of bilateral greater occipital nerve block in the management of headache pain related to SAH

Conditions and MedDRA coding

headache pain related to SAH

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients with diffuse or perimesencephalic aSAH admitted to the Semicritical Care Unit or ICU of Hospital de la Santa Creu i Sant Pau.
2. Hunt and Hess scale 1-3 (see Annex 3).
3. Signed informed consent from the patient or their representative.

Exclusion criteria 11

1. Presence of other causes of secondary headache (AVM, space-occupying lesions, etc.).
2. Convexity SAH.
3. Hunt and Hess scale 4 or 5 (see Annex 3).
4. History of allergic reaction to local anesthetic
5. Severe functional dependence (mRS 4-5, see Annex 7).
6. GCS ≤8 prior to the procedure (see Annex 4).
7. Intracranial surgery ≤1 month prior or planned during hospitalization (excluding ventricular drains).
8. Known terminal illness or imminent limitation of therapeutic effort.
9. Difficulty or foreseeable loss of clinical follow-up.
10. Pregnancy or breastfeeding.
11. Cardiac conduction disorders: Second- or third-degree atrioventricular block. Arrhythmias with hemodynamic instability.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite variable consisting of headache reduction measured with the Numerical Pain Rating Scale (NPRS) at 1 hour post-procedure, defined as a ≥30% reduction (partial response) or ≥50% reduction (optimal effect) as dichotomous variables (yes/no; n, %), and/or the absence of headache within the first hour after the procedure.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Sponsor organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Address

Calle Sant Quinti 77-79

City

Barcelona

Postcode

08041

Country

Spain

Scientific contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

Alejandra Espinosa

Public contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

Alejandra Espinosa

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 6 files

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

Application history

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