Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage (SATURN)

March 27, 2025 updated by: University Hospital, Grenoble

Evaluation of the Efficacy of Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage (SAH) After Training of Neurosurgical Intensive Care Nurses.

Non-traumatic SAH, linked in 85% of cases to the rupture of an intracranial aneurysm, is a serious stroke affecting young people. Half of all survivors suffer cognitive impairment. The presentation is that of a sudden-onset, isolated headache. This population is exposed to headache during hospitalization, which lasts an average of 13 days. This length of hospitalization is due to the fact that these patients must be monitored during the potential vasospasm period that occurs between days 4 and 14 after SAH. The pain associated with SAH is a source of discomfort and increased morphine consumption during the ICU stay, particularly during the first 10 days. Current recommendations call for conventional pain management with a combination of tier 1, 2 and/or 3 analgesics. For headache control, opioids are widely prescribed, sometimes in high doses, with adverse effects, despite efforts to reduce their use. Maximum headache pain scores remain high, indicating inadequate pain management. This highlights the urgent need to study alternative opioid-sparing and analgesia strategies for patients with SAH.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Sphenopalatine block is already used for certain types of facial and cranial pain, and could help save morphine consumption during hospitalization. The sphenopalatine ganglion is a crossroads for parasympathetic, sympathetic and sensory pathways. Recently studied in post-puncture dural breaches with promising results, sphenopalatine ganglion block (SPGN) may appear as an interesting alternative therapy in the treatment of SAH headaches. Other advantages of this block are its simplicity, efficacy and the absence of any noticeable adverse effects at the time it is performed. What's more, it is already used routinely in our department, with rapid and effective action. The hypothesis of the trial would be to reduce morphine consumption by at least 50% for patients benefiting from BGSP, for better neurological monitoring and optimal overall pain management in SAH.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Pain management according to the protocol in force in the neurosurgical intensive care unit (analgesics: Paracetamol, Nefopam and morphine PCA).
Experimental: Sphenopalatine Ganglion Block using 2% lidocaine
Addition of (BGSP) Sphenopalatine ganglion block with Lidocaine 2% Injectable Solution (2mg/ml) 1.5ml * 3 consecutive times maximum if EN >3/10, to be repeated every 12h for 7 days if necessary. BGSP performed by the department's Ides after training by the anesthetists.
Procedure: Sphenopalatine Ganglion Block using 2% lidocaine
A hollow-stem swab soaked in viscous Xylocaine is inserted into the patient's nasal cavity (one swab per nostril) until it stops. 1.5ml Lidocaine 20% (20mg/ml) is injected into each swab using a 5ml syringe and a pink trocar. Both swabs are left in place for 10 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate a 50% change in morphine consumption with sphenopalatine ganglion block during the first 72 hours after cerebral arteriography
Time Frame: during 72 hours
Total morphine consumption in mg in the first 72 hours after cerebral arteriography in the Intensive care (ICU)
during 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate a significant 3-point change in pain on EN (Simple Numerical Scale)averaged over 7 days after arteriography
Time Frame: during 7 days
EN (Simple Numerical Scale) 7-day average
during 7 days
Describe morphine consumption per day during the patient's hospitalization for the 2 groups
Time Frame: during hospitalization or 10 days
Morphine consumption in mg per day during hospitalization.
during hospitalization or 10 days
Describe the complications associated with sphenopalatine ganglion block.
Time Frame: during 7 days
Complications of the sphenopalatine ganglion block technique: incidence of soft palate anesthesia (false liquid routes at H+2), epistaxis, vasovagal reactions, transient hearing loss
during 7 days
Evaluate the feasibility of the (BGSP) sphenopalatine ganglion block act performed by Ides
Time Frame: during 7 days
Number of sphenopalatine ganglion block (BGSP) failures
during 7 days
Demonstrate that the sphenopalatine ganglion block strategy changes headaches at 28 days.
Time Frame: at 28 days
EN (Simple Numerical Scale) at Day 28, consumption of stage 3 analgesics or neuropathic
at 28 days
Demonstrate that the sphenopalatine ganglion block strategy changes patient satisfaction at Day 28
Time Frame: at 28 days
Questionnaire on overall satisfaction with pain management
at 28 days
Evaluation of nursing practices on the BGSP technique
Time Frame: up to 28 days
Satisfaction questionnaire for nurses
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU GRENOBLE ALPES / SATURN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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