NCT05136625

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

October 18, 2021

Last Update Submit

November 15, 2021

Conditions

Post Operative PainCraniofacial Pain

Keywords

sphenopalatine ganglion blockpost-craniotomy pain

Outcome Measures

Primary Outcomes (24)

  • 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 Outcomes (3)

  • Adverse effect

    Immediately post-op, 1°-2°-3°-4°-30°-60°180° days post-op

  • Vegetative response (Heart rate)

    1-5-10 min from skull pin closure. 1-5-10 min from skin incision

  • Vegetative response (Arterial pressure)

    1-5-10 min from skull pin closure. 1-5-10 min from skin incision

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: Standard Preparation

Treatment

EXPERIMENTAL

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

Drug: Sphenopalatine ganglion blockDrug: Standard Preparation

Interventions

Sphenopalatine ganglion blockDRUG

A cotton swab soaked in levobupivacaine 7,5% in inserted into the nose to block sphenopalatine ganglion, with the classic technique previously described

Treatment
Standard PreparationDRUG

Troncular scalp blockade. Local site infiltration

ControlTreatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • supratentorial craniotomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sant'Anna Hospital

Ferrara, Emilia-Romagna, 44124, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 32821444BACKGROUND

  • 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.

    PMID: 33013036BACKGROUND

  • 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.

    PMID: 29442191BACKGROUND

  • 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.

    PMID: 25343051BACKGROUND

  • 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.

    PMID: 38262005DERIVED

MeSH Terms

Conditions

Pain, PostoperativeFacial Pain

Interventions

Sphenopalatine Ganglion BlockReference Standards

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve BlockNerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeWeights and MeasuresInvestigative Techniques

Study Officials

  • Pasquale De Bonis, MD PhD

    Università degli Studi di Ferrara

    STUDY CHAIR

Central Study Contacts

Alba Scerrati, MD

CONTACT

3381402733scrlba@unife.it

Giorgio Mantovani, MD

CONTACT

3491974608mntgrg@unife.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2021

First Posted

November 29, 2021

Study Start

February 1, 2021

Primary Completion

January 31, 2024

Study Completion

June 30, 2024

Last Updated

November 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)