Subarachnoid Hemorrhage in Adult PatientsSATURNNCT06735261
Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage
A study testing Sphenopalatine Ganglion Block using 2% lidocaine in people with Subarachnoid Hemorrhage in Adult Patients, run by University Hospital, Grenoble.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage in Adult Patients
- What is being tested?
- Sphenopalatine Ganglion Block using 2% lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Sphenopalatine Ganglion Block using 2% lidocaine
- Keywords
- pain, adulte, intensive care, subarachnoid hemorrhage, securing aneurysm, lidocaine
- Medical subject headings
- Pain, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion Block using 2% lidocaineProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Pain management according to the protocol in force in the neurosurgical intensive care unit (analgesics: Paracetamol, Nefopam and morphine PCA). |
| Sphenopalatine Ganglion Block using 2% lidocaine | Experimental | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate a 50% change in morphine consumption with sphenopalatine ganglion block during the first 72 hours after cerebral arteriography
Total morphine consumption in mg in the first 72 hours after cerebral arteriography in the Intensive care (ICU)
Measured: during 72 hours
Secondary outcomes (7)
Demonstrate a significant 3-point change in pain on EN (Simple Numerical Scale)averaged over 7 days after arteriography
EN (Simple Numerical Scale) 7-day average
Measured: during 7 days
Describe morphine consumption per day during the patient's hospitalization for the 2 groups
Morphine consumption in mg per day during hospitalization.
Measured: during hospitalization or 10 days
Describe the complications associated with sphenopalatine ganglion block.
Complications of the sphenopalatine ganglion block technique: incidence of soft palate anesthesia (false liquid routes at H+2), epistaxis, vasovagal reactions, transient hearing loss
Measured: during 7 days
Evaluate the feasibility of the (BGSP) sphenopalatine ganglion block act performed by Ides
Number of sphenopalatine ganglion block (BGSP) failures
Measured: during 7 days
Demonstrate that the sphenopalatine ganglion block strategy changes headaches at 28 days.
EN (Simple Numerical Scale) at Day 28, consumption of stage 3 analgesics or neuropathic
Measured: at 28 days
Demonstrate that the sphenopalatine ganglion block strategy changes patient satisfaction at Day 28
Questionnaire on overall satisfaction with pain management
Measured: at 28 days
Evaluation of nursing practices on the BGSP technique
Satisfaction questionnaire for nurses
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Apr 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage in Adult PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-center, randomized, open-label study,
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735261
- Sponsor's protocol ID
- CHU GRENOBLE ALPES / SATURN
- Acronym
- SATURN
- Status last verified
- Mar 2025
- First submitted
- 3 Dec 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nair AS, Rayani BK. Sphenopalatine ganglion block for relieving postdural puncture headache: technique and mechanism of action of block with a narrative review of efficacy. Korean J Pain. 2017 Apr;30(2):93-97. doi: 10.3344/kjp.2017.30.2.93. Epub 2017 Mar 31.
PubMed 28416992Hung KC, Chen JY, Ho CN, Sun CK. Use of sphenopalatine ganglion block in patients with postdural puncture headache: a pilot meta-analysis. Br J Anaesth. 2021 Jan;126(1):e25-e27. doi: 10.1016/j.bja.2020.10.005. Epub 2020 Oct 31. No abstract available.
PubMed 33131755Cohen S, Levin D, Mellender S, Zhao R, Patel P, Grubb W, Kiss G. Topical Sphenopalatine Ganglion Block Compared With Epidural Blood Patch for Postdural Puncture Headache Management in Postpartum Patients: A Retrospective Review. Reg Anesth Pain Med. 2018 Nov;43(8):880-884. doi: 10.1097/AAP.0000000000000840.
PubMed 30063655Viswanathan V, Lucke-Wold B, Jones C, Aiello G, Li Y, Ayala A, Fox WC, Maciel CB, Busl KM. Change in opioid and analgesic use for headaches after aneurysmal subarachnoid hemorrhage over time. Neurochirurgie. 2021 Sep;67(5):427-432. doi: 10.1016/j.neuchi.2021.03.006. Epub 2021 Mar 23.
PubMed 33771620Kent S, Mehaffey G. Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache in obstetric patients. J Clin Anesth. 2016 Nov;34:194-6. doi: 10.1016/j.jclinane.2016.04.009. Epub 2016 May 11.
PubMed 27687372Takmaz SA, Karaoglan M, Baltaci B, Bektas M, Basar H. Transnasal Sphenopalatine Ganglion Block for Management of Postdural Puncture Headache in Non-Obstetric Patients. J Nippon Med Sch. 2021;88(4):291-295. doi: 10.1272/jnms.JNMS.2021_88-406.
PubMed 34471063Siegler BH, Dos Santos Pereira RP, Kessler J, Wallwiener S, Wallwiener M, Larmann J, Picardi S, Carr R, Weigand MA, Oehler B. Intranasal Lidocaine Administration via Mucosal Atomization Device: A Simple and Successful Treatment for Postdural Puncture Headache in Obstetric Patients. Biomedicines. 2023 Dec 13;11(12):3296. doi: 10.3390/biomedicines11123296.
PubMed 38137518Singh S, Iqbal J, Jahan N, Yadav R. Sphenopalatine Ganglion Block for the Treatment of Severe Headache following a Ruptured Aneurysm. Neurol India. 2022 Nov-Dec;70(6):2452-2453. doi: 10.4103/0028-3886.364060. No abstract available.
PubMed 36537435
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage (SAH) After Training of Neurosurgical Intensive Care Nurses.
- ClinicalTrials.gov ID
- NCT06735261
- Acronym / sponsor ID
- SATURN / CHU GRENOBLE ALPES / SATURN
- Keywords
- pain, adulte, intensive care, subarachnoid hemorrhage, securing aneurysm, lidocaine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-center, randomized, open-label study,
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Pain management according to the protocol in force in the neurosurgical intensive care unit (analgesics: Paracetamol, Nefopam and morphine PCA). |
| Sphenopalatine Ganglion Block using 2% lidocaine | Experimental | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphenopalatine Ganglion Block using 2% lidocaineA 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. | Procedure or surgery | – |
Primary outcome
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)
7 secondary outcomes
Demonstrate a significant 3-point change in pain on EN (Simple Numerical Scale)averaged over 7 days after arteriography
Time frame: during 7 days
Describe morphine consumption per day during the patient's hospitalization for the 2 groups
Time frame: during hospitalization or 10 days
Describe the complications associated with sphenopalatine ganglion block.
Time frame: during 7 days
Evaluate the feasibility of the (BGSP) sphenopalatine ganglion block act performed by Ides
Time frame: during 7 days
Demonstrate that the sphenopalatine ganglion block strategy changes headaches at 28 days.
Time frame: at 28 days
Demonstrate that the sphenopalatine ganglion block strategy changes patient satisfaction at Day 28
Time frame: at 28 days
Evaluation of nursing practices on the BGSP technique
Time frame: up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 28416992Nair AS, Rayani BK. Sphenopalatine ganglion block for relieving postdural puncture headache: technique and mechanism of action of block with a narrative review of efficacy. Korean J Pain. 2017 Apr;30(2):93-97. doi: 10.3344/kjp.2017.30.2.93. Epub 2017 Mar 31.
- Background: PubMed 33131755Hung KC, Chen JY, Ho CN, Sun CK. Use of sphenopalatine ganglion block in patients with postdural puncture headache: a pilot meta-analysis. Br J Anaesth. 2021 Jan;126(1):e25-e27. doi: 10.1016/j.bja.2020.10.005. Epub 2020 Oct 31. No abstract available.
- Background: PubMed 30063655Cohen S, Levin D, Mellender S, Zhao R, Patel P, Grubb W, Kiss G. Topical Sphenopalatine Ganglion Block Compared With Epidural Blood Patch for Postdural Puncture Headache Management in Postpartum Patients: A Retrospective Review. Reg Anesth Pain Med. 2018 Nov;43(8):880-884. doi: 10.1097/AAP.0000000000000840.
- Background: PubMed 33771620Viswanathan V, Lucke-Wold B, Jones C, Aiello G, Li Y, Ayala A, Fox WC, Maciel CB, Busl KM. Change in opioid and analgesic use for headaches after aneurysmal subarachnoid hemorrhage over time. Neurochirurgie. 2021 Sep;67(5):427-432. doi: 10.1016/j.neuchi.2021.03.006. Epub 2021 Mar 23.
- Background: PubMed 27687372Kent S, Mehaffey G. Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache in obstetric patients. J Clin Anesth. 2016 Nov;34:194-6. doi: 10.1016/j.jclinane.2016.04.009. Epub 2016 May 11.
- Background: PubMed 34471063Takmaz SA, Karaoglan M, Baltaci B, Bektas M, Basar H. Transnasal Sphenopalatine Ganglion Block for Management of Postdural Puncture Headache in Non-Obstetric Patients. J Nippon Med Sch. 2021;88(4):291-295. doi: 10.1272/jnms.JNMS.2021_88-406.
- Background: PubMed 38137518Siegler BH, Dos Santos Pereira RP, Kessler J, Wallwiener S, Wallwiener M, Larmann J, Picardi S, Carr R, Weigand MA, Oehler B. Intranasal Lidocaine Administration via Mucosal Atomization Device: A Simple and Successful Treatment for Postdural Puncture Headache in Obstetric Patients. Biomedicines. 2023 Dec 13;11(12):3296. doi: 10.3390/biomedicines11123296.
- Background: PubMed 36537435Singh S, Iqbal J, Jahan N, Yadav R. Sphenopalatine Ganglion Block for the Treatment of Severe Headache following a Ruptured Aneurysm. Neurol India. 2022 Nov-Dec;70(6):2452-2453. doi: 10.4103/0028-3886.364060. No abstract available.
- Lidocaine ToxicityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine Ganglion Block using 2% lidocaine in people with Subarachnoid Hemorrhage in Adult Patients, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FELIX FP PELEN, Anesthesiologist (04 76 76 67 29 ext. +33, pfpelen@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate a 50% change in morphine consumption with sphenopalatine ganglion block during the first 72 hours after cerebral arteriography (time frame: during 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06735261, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.