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Sphenopalatine Ganglion Block and Pain Management in Neurosurgery (SpheNoPain)

Primary Purpose

Post Operative Pain, Craniofacial Pain

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sphenopalatine ganglion block
Standard Preparation
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring sphenopalatine ganglion block, post-craniotomy pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • supratentorial craniotomy

Exclusion Criteria:

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

Sites / Locations

  • Sant'Anna HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever)
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)

Secondary Outcome Measures

Adverse effect
Bitter taste, nose bleeding, throat discomfort
Vegetative response (Heart rate)
Heart rate in beat per minute
Vegetative response (Arterial pressure)
Mean arterial pressure in mmHg

Full Information

First Posted
October 18, 2021
Last Updated
November 15, 2021
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT05136625
Brief Title
Sphenopalatine Ganglion Block and Pain Management in Neurosurgery
Acronym
SpheNoPain
Official Title
Sphenopalatine Ganglion Block and Pain Management in Neurosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Craniofacial Pain
Keywords
sphenopalatine ganglion block, post-craniotomy pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine)
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%)
Intervention Type
Drug
Intervention Name(s)
Sphenopalatine ganglion block
Intervention Description
A cotton swab soaked in levobupivacaine 7,5% in inserted into the nose to block sphenopalatine ganglion, with the classic technique previously described
Intervention Type
Drug
Intervention Name(s)
Standard Preparation
Intervention Description
Troncular scalp blockade. Local site infiltration
Primary Outcome Measure Information:
Title
Numerical Rating Scale
Description
From 0 (no pain) to 10 (worst pain ever)
Time Frame
Immediately post-op
Title
Numerical Rating Scale
Description
From 0 (no pain) to 10 (worst pain ever)
Time Frame
1° days post-op
Title
Numerical Rating Scale
Description
From 0 (no pain) to 10 (worst pain ever)
Time Frame
2° days post-op
Title
Numerical Rating Scale
Description
From 0 (no pain) to 10 (worst pain ever)
Time Frame
3° days post-op
Title
Numerical Rating Scale
Description
From 0 (no pain) to 10 (worst pain ever)
Time Frame
4° days post-op
Title
Numerical Rating Scale
Description
From 0 (no pain) to 10 (worst pain ever)
Time Frame
30° days post-op
Title
Numerical Rating Scale
Description
From 0 (no pain) to 10 (worst pain ever)
Time Frame
60° days post-op
Title
Numerical Rating Scale
Description
From 0 (no pain) to 10 (worst pain ever)
Time Frame
180° days post-op
Title
Visual Analogic Scale
Description
From 0 (no pain) to 10 (worst pain ever)
Time Frame
Immediately post-op
Title
Visual Analogic Scale
Description
From 0 (no pain) to 10 (worst pain ever) on a straight line
Time Frame
1° day post-op
Title
Visual Analogic Scale
Description
From 0 (no pain) to 10 (worst pain ever) on a straight line
Time Frame
2° day post-op
Title
Visual Analogic Scale
Description
From 0 (no pain) to 10 (worst pain ever) on a straight line
Time Frame
3° day post-op
Title
Visual Analogic Scale
Description
From 0 (no pain) to 10 (worst pain ever) on a straight line
Time Frame
4° day post-op
Title
Visual Analogic Scale
Description
From 0 (no pain) to 10 (worst pain ever) on a straight line
Time Frame
30° day post-op
Title
Visual Analogic Scale
Description
From 0 (no pain) to 10 (worst pain ever) on a straight line
Time Frame
60° day post-op
Title
Visual Analogic Scale
Description
From 0 (no pain) to 10 (worst pain ever) on a straight line
Time Frame
180° day post-op
Title
Pain Assessment IN Advanced Dementia
Description
From 0 (no signs of pain) to 10 (Extreme pain)
Time Frame
Immediately post-op
Title
Pain Assessment IN Advanced Dementia
Description
From 0 (no signs of pain) to 10 (Extreme pain)
Time Frame
1° day post-op
Title
Pain Assessment IN Advanced Dementia
Description
From 0 (no signs of pain) to 10 (Extreme pain)
Time Frame
2° day post-op
Title
Pain Assessment IN Advanced Dementia
Description
From 0 (no signs of pain) to 10 (Extreme pain)
Time Frame
3° day post-op
Title
Pain Assessment IN Advanced Dementia
Description
From 0 (no signs of pain) to 10 (Extreme pain)
Time Frame
4° day post-op
Title
Pain Assessment IN Advanced Dementia
Description
From 0 (no signs of pain) to 10 (Extreme pain)
Time Frame
30° day post-op
Title
Pain Assessment IN Advanced Dementia
Description
From 0 (no signs of pain) to 10 (Extreme pain)
Time Frame
60° day post-op
Title
Pain Assessment IN Advanced Dementia
Description
From 0 (no signs of pain) to 10 (Extreme pain)
Time Frame
180° day post-op
Secondary Outcome Measure Information:
Title
Adverse effect
Description
Bitter taste, nose bleeding, throat discomfort
Time Frame
Immediately post-op, 1°-2°-3°-4°-30°-60°180° days post-op
Title
Vegetative response (Heart rate)
Description
Heart rate in beat per minute
Time Frame
1-5-10 min from skull pin closure. 1-5-10 min from skin incision
Title
Vegetative response (Arterial pressure)
Description
Mean arterial pressure in mmHg
Time Frame
1-5-10 min from skull pin closure. 1-5-10 min from skin incision

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: supratentorial craniotomy Exclusion Criteria: prior craniofacial pain syndrome drug assumption: pain-killers (chronic), antiepileptic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alba Scerrati, MD
Phone
3381402733
Email
scrlba@unife.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giorgio Mantovani, MD
Phone
3491974608
Email
mntgrg@unife.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasquale De Bonis, MD PhD
Organizational Affiliation
Università degli Studi di Ferrara
Official's Role
Study Chair
Facility Information:
Facility Name
Sant'Anna Hospital
City
Ferrara
State/Province
Emilia Romagna
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alba Scerrati, MD
Phone
3381402733
Email
scrlba@unife.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32821444
Citation
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.
Results Reference
background
PubMed Identifier
33013036
Citation
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.
Results Reference
background
PubMed Identifier
29442191
Citation
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.
Results Reference
background
PubMed Identifier
25343051
Citation
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.
Results Reference
background

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Sphenopalatine Ganglion Block and Pain Management in Neurosurgery

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