Sphenopalatine Ganglion Block and Pain Management in Neurosurgery (SpheNoPain)

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain; Craniofacial Pain
• Intervention / Treatment: Drug: Standard Preparation; Drug: Sphenopalatine ganglion block

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alba Scerrati, MD; Phone Number: 3381402733; Email: scrlba@unife.it
• Study Contact Backup: Name: Giorgio Mantovani, MD; Phone Number: 3491974608; Email: mntgrg@unife.it

Study Locations

• Italy
  • Emilia Romagna
    • Ferrara, Emilia Romagna, Italy, 44124
      • Recruiting
      • Sant'Anna Hospital
      • Contact: Alba Scerrati, MD; Phone Number: 3381402733; Email: scrlba@unife.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• supratentorial craniotomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine)	Drug: Standard Preparation; Troncular scalp blockade. Local site infiltration
Experimental: Treatment; Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%)	Drug: Standard Preparation; Troncular scalp blockade. Local site infiltration; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	Immediately post-op
Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	1° days post-op
Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	2° days post-op
Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	3° days post-op
Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	4° days post-op
Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	30° days post-op
Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	60° days post-op
Numerical Rating Scale	From 0 (no pain) to 10 (worst pain ever)	180° days post-op
Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever)	Immediately post-op
Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	1° day post-op
Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	2° day post-op
Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	3° day post-op
Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	4° day post-op
Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	30° day post-op
Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	60° day post-op
Visual Analogic Scale	From 0 (no pain) to 10 (worst pain ever) on a straight line	180° day post-op
Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	Immediately post-op
Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	1° day post-op
Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	2° day post-op
Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	3° day post-op
Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	4° day post-op
Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	30° day post-op
Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	60° day post-op
Pain Assessment IN Advanced Dementia	From 0 (no signs of pain) to 10 (Extreme pain)	180° day post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effect	Bitter taste, nose bleeding, throat discomfort	Immediately post-op, 1°-2°-3°-4°-30°-60°180° days post-op
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
Vegetative response (Arterial pressure)	Mean arterial pressure in mmHg	1-5-10 min from skull pin closure. 1-5-10 min from skin incision

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara
• Investigators: Study Chair: Pasquale De Bonis, MD PhD, Università degli Studi di Ferrara

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: sphenopalatine ganglion block; post-craniotomy pain
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Postoperative Complications; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Pain, Postoperative; Facial Pain; Ganglion Cysts
• Other Study ID Numbers: 553/2021/Sper/AOUFe

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