Post Operative PainSpheNoPainNCT05136625
Sphenopalatine Ganglion Block and Pain Management in Neurosurgery
A study testing Sphenopalatine ganglion block and Standard Preparation in people with Post Operative Pain and Craniofacial Pain, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Craniofacial Pain
- What is being tested?
- Sphenopalatine ganglion block and Standard Preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- supratentorial craniotomy
Who cannot join
- prior craniofacial pain syndrome
- drug assumption: pain-killers (chronic), antiepileptic
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Sant'Anna Hospital
Ferrara, Emilia-Romagna, 44124
Alba Scerrati, MD, 3381402733, scrlba@unife.it
About this study
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.
- Conditions
- Post Operative Pain, Craniofacial Pain
- Being tested
- Sphenopalatine ganglion block, Standard Preparation
- Keywords
- sphenopalatine ganglion block, post-craniotomy pain
- Medical subject headings
- Pain, Postoperative, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Standard PreparationDrug
Troncular scalp blockade. Local site infiltration
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Receives: Drug: Standard Preparation |
| Treatment | Experimental | Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%) Receives: Drug: Sphenopalatine ganglion block; Drug: Standard Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Measured: Immediately post-op
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Measured: 1° days post-op
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Measured: 2° days post-op
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Measured: 3° days post-op
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Measured: 4° days post-op
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Measured: 30° days post-op
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Measured: 60° days post-op
Numerical Rating Scale
From 0 (no pain) to 10 (worst pain ever)
Measured: 180° days post-op
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever)
Measured: Immediately post-op
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Measured: 1° day post-op
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Measured: 2° day post-op
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Measured: 3° day post-op
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Measured: 4° day post-op
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Measured: 30° day post-op
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Measured: 60° day post-op
Visual Analogic Scale
From 0 (no pain) to 10 (worst pain ever) on a straight line
Measured: 180° day post-op
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Measured: Immediately post-op
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Measured: 1° day post-op
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Measured: 2° day post-op
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Measured: 3° day post-op
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Measured: 4° day post-op
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Measured: 30° day post-op
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Measured: 60° day post-op
Pain Assessment IN Advanced Dementia
From 0 (no signs of pain) to 10 (Extreme pain)
Measured: 180° day post-op
Secondary outcomes (3)
Adverse effect
Bitter taste, nose bleeding, throat discomfort
Measured: Immediately post-op, 1°-2°-3°-4°-30°-60°180° days post-op
Vegetative response (Heart rate)
Heart rate in beat per minute
Measured: 1-5-10 min from skull pin closure. 1-5-10 min from skin incision
Vegetative response (Arterial pressure)
Mean arterial pressure in mmHg
Measured: 1-5-10 min from skull pin closure. 1-5-10 min from skin incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 Feb 2021
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pasquale De Bonis, MD PhD, Study chair, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136625
- Sponsor's protocol ID
- 553/2021/Sper/AOUFe
- Acronym
- SpheNoPain
- Status last verified
- Sep 2021
- First submitted
- 18 Oct 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32821444Padhy 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.
PubMed 33013036Crespi 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.
PubMed 29442191Elahi 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.
PubMed 25343051Mantovani 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.
PubMed 38262005
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block and Pain Management in Neurosurgery
- ClinicalTrials.gov ID
- NCT05136625
- Acronym / sponsor ID
- SpheNoPain / 553/2021/Sper/AOUFe
- Conditions
- Post Operative Pain, Craniofacial Pain
- Keywords
- sphenopalatine ganglion block, post-craniotomy pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 29 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Standard PreparationTroncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) |
| Treatment | Experimental | Drug: Sphenopalatine ganglion block, Drug: Standard PreparationTroncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- supratentorial craniotomy
Key exclusion criteria (2 listed)
- prior craniofacial pain syndrome
- drug assumption: pain-killers (chronic), antiepileptic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphenopalatine ganglion blockA cotton swab soaked in levobupivacaine 7,5% in inserted into the nose to block sphenopalatine ganglion, with the classic technique previously described | Drug | Treatment |
| Standard PreparationTroncular scalp blockade. Local site infiltration | Drug | Control, Treatment |
Primary outcome
Numerical Rating Scale
Time frame: Immediately post-op
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
Time frame: 1° days post-op
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
Time frame: 2° days post-op
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
Time frame: 3° days post-op
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
Time frame: 4° days post-op
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
Time frame: 30° days post-op
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
Time frame: 60° days post-op
From 0 (no pain) to 10 (worst pain ever)
Numerical Rating Scale
Time frame: 180° days post-op
From 0 (no pain) to 10 (worst pain ever)
Visual Analogic Scale
Time frame: Immediately post-op
From 0 (no pain) to 10 (worst pain ever)
Visual Analogic Scale
Time frame: 1° day post-op
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
Time frame: 2° day post-op
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
Time frame: 3° day post-op
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
Time frame: 4° day post-op
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
Time frame: 30° day post-op
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
Time frame: 60° day post-op
From 0 (no pain) to 10 (worst pain ever) on a straight line
Visual Analogic Scale
Time frame: 180° day post-op
From 0 (no pain) to 10 (worst pain ever) on a straight line
Pain Assessment IN Advanced Dementia
Time frame: Immediately post-op
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
Time frame: 1° day post-op
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
Time frame: 2° day post-op
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
Time frame: 3° day post-op
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
Time frame: 4° day post-op
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
Time frame: 30° day post-op
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
Time frame: 60° day post-op
From 0 (no signs of pain) to 10 (Extreme pain)
Pain Assessment IN Advanced Dementia
Time frame: 180° day post-op
From 0 (no signs of pain) to 10 (Extreme pain)
3 secondary outcomes
Adverse effect
Time frame: Immediately post-op, 1°-2°-3°-4°-30°-60°180° days post-op
Vegetative response (Heart rate)
Time frame: 1-5-10 min from skull pin closure. 1-5-10 min from skin incision
Vegetative response (Arterial pressure)
Time frame: 1-5-10 min from skull pin closure. 1-5-10 min from skin incision
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Background: PubMed 32821444Sir 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.
- Background: PubMed 33013036Padhy 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.
- Background: PubMed 29442191Crespi 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.
- Background: PubMed 25343051Elahi 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.
- Derived from this study: PubMed 38262005Mantovani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasquale De Bonis, MD PhD study chair
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine ganglion block and Standard Preparation in people with Post Operative Pain and Craniofacial Pain, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alba Scerrati, MD (3381402733, scrlba@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: Immediately post-op). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05136625, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.