Sphenopalatine Ganglion Block and Pain Management in Neurosurgery

Study Overview
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Brief Summary
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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.

Official Title
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Sphenopalatine Ganglion Block and Pain Management in Neurosurgery

Conditions
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Post Operative Pain, Craniofacial Pain

Intervention / Treatment
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* Drug: Sphenopalatine ganglion block
* Drug: Standard Preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: supratentorial craniotomy Exclusion Criteria: prior craniofacial pain syndrome drug assumption: pain-killers (chronic), antiepileptic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) | Drug: Standard Preparation<br>* Troncular scalp blockade. Local site infiltration<br>|
| Experimental: Treatment<br>Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%) | Drug: Sphenopalatine ganglion block<br>* A cotton swab soaked in levobupivacaine 7,5% in inserted into the nose to block sphenopalatine ganglion, with the classic technique previously described<br>Drug: Standard Preparation<br>* Troncular scalp blockade. Local site infiltration<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sphenopalatine ganglion block, post-craniotomy pain