SpheNoPain: Sphenopalatine Ganglion Block and Pain Management in Neurosurgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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: 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
Drug: Standard Preparation
Troncular scalp blockade. Local site infiltration
|
Outcome Measures
Primary Outcome Measures
- Numerical Rating Scale [Immediately post-op]
From 0 (no pain) to 10 (worst pain ever)
- Numerical Rating Scale [1° days post-op]
From 0 (no pain) to 10 (worst pain ever)
- Numerical Rating Scale [2° days post-op]
From 0 (no pain) to 10 (worst pain ever)
- Numerical Rating Scale [3° days post-op]
From 0 (no pain) to 10 (worst pain ever)
- Numerical Rating Scale [4° days post-op]
From 0 (no pain) to 10 (worst pain ever)
- Numerical Rating Scale [30° days post-op]
From 0 (no pain) to 10 (worst pain ever)
- Numerical Rating Scale [60° days post-op]
From 0 (no pain) to 10 (worst pain ever)
- Numerical Rating Scale [180° days post-op]
From 0 (no pain) to 10 (worst pain ever)
- Visual Analogic Scale [Immediately post-op]
From 0 (no pain) to 10 (worst pain ever)
- Visual Analogic Scale [1° day post-op]
From 0 (no pain) to 10 (worst pain ever) on a straight line
- Visual Analogic Scale [2° day post-op]
From 0 (no pain) to 10 (worst pain ever) on a straight line
- Visual Analogic Scale [3° day post-op]
From 0 (no pain) to 10 (worst pain ever) on a straight line
- Visual Analogic Scale [4° day post-op]
From 0 (no pain) to 10 (worst pain ever) on a straight line
- Visual Analogic Scale [30° day post-op]
From 0 (no pain) to 10 (worst pain ever) on a straight line
- Visual Analogic Scale [60° day post-op]
From 0 (no pain) to 10 (worst pain ever) on a straight line
- Visual Analogic Scale [180° day post-op]
From 0 (no pain) to 10 (worst pain ever) on a straight line
- Pain Assessment IN Advanced Dementia [Immediately post-op]
From 0 (no signs of pain) to 10 (Extreme pain)
- Pain Assessment IN Advanced Dementia [1° day post-op]
From 0 (no signs of pain) to 10 (Extreme pain)
- Pain Assessment IN Advanced Dementia [2° day post-op]
From 0 (no signs of pain) to 10 (Extreme pain)
- Pain Assessment IN Advanced Dementia [3° day post-op]
From 0 (no signs of pain) to 10 (Extreme pain)
- Pain Assessment IN Advanced Dementia [4° day post-op]
From 0 (no signs of pain) to 10 (Extreme pain)
- Pain Assessment IN Advanced Dementia [30° day post-op]
From 0 (no signs of pain) to 10 (Extreme pain)
- Pain Assessment IN Advanced Dementia [60° day post-op]
From 0 (no signs of pain) to 10 (Extreme pain)
- Pain Assessment IN Advanced Dementia [180° day post-op]
From 0 (no signs of pain) to 10 (Extreme pain)
Secondary Outcome Measures
- Adverse effect [Immediately post-op, 1°-2°-3°-4°-30°-60°180° days post-op]
Bitter taste, nose bleeding, throat discomfort
- Vegetative response (Heart rate) [1-5-10 min from skull pin closure. 1-5-10 min from skin incision]
Heart rate in beat per minute
- Vegetative response (Arterial pressure) [1-5-10 min from skull pin closure. 1-5-10 min from skin incision]
Mean arterial pressure in mmHg
Eligibility Criteria
Criteria
Inclusion Criteria:
- supratentorial craniotomy
Exclusion Criteria:
-
prior craniofacial pain syndrome
-
drug assumption: pain-killers (chronic), antiepileptic
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sant'Anna Hospital | Ferrara | Emilia Romagna | Italy | 44124 |
Sponsors and Collaborators
- University Hospital of Ferrara
Investigators
- Study Chair: Pasquale De Bonis, MD PhD, Università degli Studi di Ferrara
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 553/2021/Sper/AOUFe