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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) |
|
| Treatment | Experimental | Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphenopalatine ganglion block | Drug | A cotton swab soaked in levobupivacaine 7,5% in inserted into the nose to block sphenopalatine ganglion, with the classic technique previously described |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alba Scerrati, MD | Contact | 3381402733 | scrlba@unife.it | |
| Giorgio Mantovani, MD | Contact | 3491974608 | mntgrg@unife.it |
| Name | Affiliation | Role |
|---|---|---|
| Pasquale De Bonis, MD PhD | Università degli Studi di Ferrara | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sant'Anna Hospital | Recruiting | Ferrara | Emilia-Romagna | 44124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32821444 | Background | 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. | |
| 33013036 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| D012015 | Reference Standards |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
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| Standard Preparation | Drug | Troncular scalp blockade. Local site infiltration |
|
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 |
| 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 |
| 29442191 | Background | 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. |
| 25343051 | Background | 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. |
| 38262005 | Derived | Mantovani G, Sgarbanti L, Indaimo A, Cavallo MA, De Bonis P, Flacco ME, Scerrati A. Effects of a sphenopalatine ganglion block on postcraniotomy pain management: a randomized, double-blind, clinical trial. Neurosurg Focus. 2023 Dec;55(6):E13. doi: 10.3171/2023.9.FOCUS23549. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000760 |
| Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |