CClinicalTrials.gg
Not yet recruitingNCT06735261SATURNUpdated Mar 28, 2025

Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage

An interventional study of Sphenopalatine Ganglion Block using 2% lidocaine in Subarachnoid Hemorrhage in Adult Patients, sponsored by University Hospital, Grenoble. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Subarachnoid Hemorrhage in Adult Patients

Keywords

  • pain
  • adulte
  • intensive care
  • subarachnoid hemorrhage
  • securing aneurysm
  • lidocaine
03

In context

Subarachnoid Hemorrhage

509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.

This study's planned enrollment of 70 is above the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • 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.

Interventions

  • ProcedureSphenopalatine 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: during 72 hours

Secondary outcomes

  1. 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

    Time frame: during 7 days

  2. Describe morphine consumption per day during the patient's hospitalization for the 2 groups

    Morphine consumption in mg per day during hospitalization.

    Time frame: during hospitalization or 10 days

  3. 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

    Time frame: during 7 days

  4. Evaluate the feasibility of the (BGSP) sphenopalatine ganglion block act performed by Ides

    Number of sphenopalatine ganglion block (BGSP) failures

    Time frame: during 7 days

  5. 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

    Time frame: at 28 days

  6. Demonstrate that the sphenopalatine ganglion block strategy changes patient satisfaction at Day 28

    Questionnaire on overall satisfaction with pain management

    Time frame: at 28 days

  7. Evaluation of nursing practices on the BGSP technique

    Satisfaction questionnaire for nurses

    Time frame: up to 28 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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 28416992 ↗
  • Hung 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 33131755 ↗
  • Cohen 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 30063655 ↗
  • Viswanathan 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 33771620 ↗
  • Kent 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 27687372 ↗
  • Takmaz 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 34471063 ↗
  • Siegler 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 38137518 ↗
  • Singh 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06735261
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Dec 16, 2024
Start date
Apr 1, 2025 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 28, 2025

Study contacts

FELIX FP PELEN, Anesthesiologist
Contact
pfpelen@chu-grenoble.fr
04 76 76 67 29 ext. +33
Angélina AP POLLET, RESEARCH NURSE
Contact
apollet@chu-grenoble.fr
07476766729 ext. +33

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion