Clinical trial NCT05136625: Sphenopalatine Ganglion Block and Pain Management in Neurosurgery
Official title: Sphenopalatine Ganglion Block and Pain Management in Neurosurgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Craniofacial Pain
Keywords: sphenopalatine ganglion block
post-craniotomy pain
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post craniotomy pain is defined as headache developed up to 7 days from a craniotomy, not otherwise explained. A moderate to severe pain affects from 60 to 84% of patients.

Sphenopalatine ganglion block has been successfully used in patients with chronic or acute headache, facial pain and for transsphenoidal pituitary and endoscopic sinus surgeries.

There are evidences that sphenopalatine ganglion block reduces vegetative responses to skull pin closure.

This study aim to investigate feasibility and efficacy of sphenopalatine ganglion block in reducing pain after a neurosurgical supratentorial craniotomy.


Eligibility criteria: Inclusion Criteria:

* supratentorial craniotomy

Exclusion Criteria:

* prior craniofacial pain syndrome
* drug assumption: pain-killers (chronic), antiepileptic

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: Immediately post-op
measure: Numerical Rating Scale
timeFrame: 1° days post-op
measure: Numerical Rating Scale
timeFrame: 2° days post-op
measure: Numerical Rating Scale
timeFrame: 3° days post-op
measure: Numerical Rating Scale
timeFrame: 4° days post-op
measure: Numerical Rating Scale
timeFrame: 30° days post-op
measure: Numerical Rating Scale
timeFrame: 60° days post-op
measure: Numerical Rating Scale
timeFrame: 180° days post-op
measure: Visual Analogic Scale
timeFrame: Immediately post-op
measure: Visual Analogic Scale
timeFrame: 1° day post-op
measure: Visual Analogic Scale
timeFrame: 2° day post-op
measure: Visual Analogic Scale
timeFrame: 3° day post-op
measure: Visual Analogic Scale
timeFrame: 4° day post-op
measure: Visual Analogic Scale
timeFrame: 30° day post-op
measure: Visual Analogic Scale
timeFrame: 60° day post-op
measure: Visual Analogic Scale
timeFrame: 180° day post-op
measure: Pain Assessment IN Advanced Dementia
timeFrame: Immediately post-op
measure: Pain Assessment IN Advanced Dementia
timeFrame: 1° day post-op
measure: Pain Assessment IN Advanced Dementia
timeFrame: 2° day post-op
measure: Pain Assessment IN Advanced Dementia
timeFrame: 3° day post-op
measure: Pain Assessment IN Advanced Dementia
timeFrame: 4° day post-op
measure: Pain Assessment IN Advanced Dementia
timeFrame: 30° day post-op
measure: Pain Assessment IN Advanced Dementia
timeFrame: 60° day post-op
measure: Pain Assessment IN Advanced Dementia
timeFrame: 180° day post-op
Secondary outcomes:
measure: Adverse effect
timeFrame: Immediately post-op, 1°-2°-3°-4°-30°-60°180° days post-op
measure: Vegetative response (Heart rate)
timeFrame: 1-5-10 min from skull pin closure. 1-5-10 min from skin incision
measure: Vegetative response (Arterial pressure)
timeFrame: 1-5-10 min from skull pin closure. 1-5-10 min from skin incision
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Sant'Anna Hospital
state: Emilia Romagna
Study officials:
affiliation: Università degli Studi di Ferrara
name: Pasquale De Bonis, MD PhD
role: STUDY_CHAIR
References:
citation: Sir E, Eksert S. Morphological Description and Clinical Implication of Sphenopalatine Foramen for Accurate Transnasal Sphenopalatine Ganglion Block: An Anatomical Study. Medeni Med J. 2019;34(3):239-243. doi: 10.5222/MMJ.2019.20586. Epub 2019 Sep 27.
citation: Padhy N, Moningi S, Kulkarni DK, Alugolu R, Inturi S, Ramachandran G. Sphenopalatine ganglion block: Intranasal transmucosal approach for anterior scalp blockade - A prospective randomized comparative study. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):207-212. doi: 10.4103/joacp.JOACP_249_18. Epub 2020 Jun 15.
citation: Crespi J, Bratbak D, Dodick D, Matharu M, Jamtoy KA, Aschehoug I, Tronvik E. Measurement and implications of the distance between the sphenopalatine ganglion and nasal mucosa: a neuroimaging study. J Headache Pain. 2018 Feb 13;19(1):14. doi: 10.1186/s10194-018-0843-5.
citation: Elahi F, Ho KW. Successful Management of Refractory Headache and Facial Pain due to Cavernous Sinus Meningioma with Sphenopalatine Ganglion Radiofrequency. Case Rep Neurol Med. 2014;2014:923516. doi: 10.1155/2014/923516. Epub 2014 Sep 29.