Sphenopalatine Ganglion Block and Pain Management in Neurosurgery

Post Operative Pain Clinical Trial

— SpheNoPain  

Official title:

Sphenopalatine Ganglion Block and Pain Management in Neurosurgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05136625
• Other study ID #: 553/2021/Sper/AOUFe
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2021
• Source: University Hospital of Ferrara
• Contact: Alba Scerrati, MD
• Phone: 3381402733
• Email: scrlba[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• supratentorial craniotomy

Exclusion Criteria:

• prior craniofacial pain syndrome

• drug assumption: pain-killers (chronic), antiepileptic

Related Conditions & MeSH terms

• Facial Pain
• Ganglion Cysts
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Sphenopalatine ganglion block
A cotton swab soaked in levobupivacaine 7,5% in inserted into the nose to block sphenopalatine ganglion, with the classic technique previously described
• Standard Preparation
Troncular scalp blockade. Local site infiltration

Locations

Country	Name	City	State
Italy	Sant'Anna Hospital	Ferrara	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Crespi J, Bratbak D, Dodick D, Matharu M, Jamtøy 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	Immediately post-op
Primary	Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	1° days post-op
Primary	Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	2° days post-op
Primary	Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	3° days post-op
Primary	Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	4° days post-op
Primary	Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	30° days post-op
Primary	Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	60° days post-op
Primary	Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	180° days post-op
Primary	Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever)	Immediately post-op
Primary	Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	1° day post-op
Primary	Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	2° day post-op
Primary	Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	3° day post-op
Primary	Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	4° day post-op
Primary	Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	30° day post-op
Primary	Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	60° day post-op
Primary	Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	180° day post-op
Primary	Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	Immediately post-op
Primary	Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	1° day post-op
Primary	Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	2° day post-op
Primary	Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	3° day post-op
Primary	Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	4° day post-op
Primary	Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	30° day post-op
Primary	Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	60° day post-op
Primary	Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	180° day post-op
Secondary	Adverse effect	Bitter taste, nose bleeding, throat discomfort	Immediately post-op, 1°-2°-3°-4°-30°-60°180° days post-op
Secondary	Vegetative response (Heart rate)	Heart rate in beat per minute	1-5-10 min from skull pin closure. 1-5-10 min from skin incision
Secondary	Vegetative response (Arterial pressure)	Mean arterial pressure in mmHg	1-5-10 min from skull pin closure. 1-5-10 min from skin incision