Sphenopalatine Ganglion Block and Pain Management in Neurosurgery (SpheNoPain)

University Hospital of Ferrara

Status: Enrolling

Conditions: Craniofacial Pain; Post Operative Pain

Treatments: Drug: Standard Preparation; Drug: Sphenopalatine ganglion block

Study type: Interventional

Funder types: Other

Identifiers

NCT05136625

553/2021/Sper/AOUFe

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• supratentorial craniotomy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Control

Active Comparator group

Description:

Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine)

Treatment:

Drug: Standard Preparation

Treatment

Experimental group

Description:

Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%)

Treatment:

Drug: Sphenopalatine ganglion block

Drug: Standard Preparation