Sphenopalatine Ganglion Nerve BlockNCT06639659
Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery
A study testing Sphenopalatine Ganglion Block and Dexmedetomidine in people with Sphenopalatine Ganglion Nerve Block and Transnasal Endoscopic Pitutary Surgery, run by Zagazig University at 1 site in Egypt.
Trial summary
Improving pain and surgical field by using sphenopalatine ganglion block and dexmedetomidine in trans-nasal endoscopic pituitary surgery. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Sphenopalatine Ganglion Nerve Block, Transnasal Endoscopic Pitutary Surgery
- What is being tested?
- Sphenopalatine Ganglion Block and Dexmedetomidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: between 21-64 years old.
- sex: males and females.
- Body mass index: 35 kg/m2.
- ASA Physical status: grade Ⅰ-Ⅱ.
Who cannot join
- patients receiving beta blockers, anti-coagulants and antihypertensive medications also patients receiving clonidine or benzodiazepines, neuroleptics or antidepressants two weeks prior to the study.
- Any contraindication for regional anesthesia e.g. coagulopathy, infection at site of block and hypersensitivity to any drug used in this study.
- Patients who are known to be drug addict.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Supra-Zygomatic Sphenopalatine Ganglion Block Versus Dexmedetomidine for Relief of Postoperative Pain and Surgical Field Improvement in Trans-nasal Endoscopic Pituitary Surgery
Improving pain and surgical field by using sphenopalatine ganglion block and dexmedetomidine in trans-nasal endoscopic pituitary surgery.
Read the detailed description
Pituitary neoplasm is one of the most common sellar pathology. Trans-nasal endoscopic pituitary surgery (TEPS) evolved rapidly, almost replacing the craniotomy approach. TEPS, a surgical instrument, is primarily executed through a minimally invasive approach through the nostril to access a pituitary tumor.
That is why the anesthetic plan must ensure the best possible surgical field visualization and the most adequate analgesia.
Multimodal anesthesia including regional and general anesthesia are obtained to optimize surgical field by decreasing bleeding, reduce pain, promote rapid recovery and potential economic gains for the hospital.
The sphenopalatine ganglion block (SPGB) is considered one of the regional anesthetic techniques that is safe and easy anesthetic procedure used to control bleeding and for postoperative analgesia.
Dexmedetomidine (DEX) has become popular for induced hypotension. It is an α2-adrenoceptor agonist with a sympatholytic and analgesic effect. It provides a unique conscious sedation without respiratory depression. It is used effectively in optimizing surgical field through its hemodynamic stability effect.
- Being tested
- Sphenopalatine Ganglion Block, Dexmedetomidine, General Anesthesia (control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion BlockProcedure or surgery
patients will receive ultrasound guided bilateral supra-zygomatic sphenopalatine ganglion block.
DexmedetomidineDrug
patients will receive 1 µg/kg dexmedetomidine within 10 minutes, followed by maintenance dose throughout the surgery.
General Anesthesia (control group)Other
patients will be operated under general anesthesia including routine protocol for these cases
| Study group | Role | What they receive |
|---|---|---|
| Group C (control group) (n=23) patients will be operated under general anesthesia. | Placebo comparator | Not described Receives: Other: General Anesthesia (control group) |
| Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block | Active comparator | Not described Receives: Procedure: Sphenopalatine Ganglion Block |
| Group DEX (n=23) patients will receive dexmedetomidine drug. | Active comparator | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain using VAS scale.
Pain will be assessed based on VAS scale from (1-10), as 1 is the least pain and 10 is the maximal pain possible at 2, 4, 6, 12 and 24h after surgery.
Measured: 24hours
Surgical field using Average Category Scale (ACS).
Done by asking the surgeon about amount of bleeding on a scale of (0-5) as 0= no bleeding and 5= sever bleeding, every 15 min interval till the end of surgery.
Measured: 5hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sphenopalatine Ganglion Nerve BlockStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639659
- Sponsor's protocol ID
- sphenopalatine block in TEPS
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anthony Cometa M, Zasimovich Y, Smith CR. Percutaneous sphenopalatine ganglion block: an alternative to the transnasal approach. Int J Obstet Anesth. 2021 Feb;45:163-164. doi: 10.1016/j.ijoa.2020.10.002. Epub 2020 Oct 17. No abstract available.
PubMed 33199256Mantovani 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 38262005Hutton M, Brull R, Macfarlane AJR. Regional anaesthesia and outcomes. BJA Educ. 2018 Feb;18(2):52-56. doi: 10.1016/j.bjae.2017.10.002. Epub 2017 Nov 27. No abstract available.
PubMed 33456810
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Supra-Zygomatic Sphenopalatine Ganglion Block Versus Dexmedetomidine for Relief of Postoperative Pain and Surgical Field Improvement in Trans-nasal Endoscopic Pituitary Surgery
- ClinicalTrials.gov ID
- NCT06639659
- Acronym / sponsor ID
- sphenopalatine block in TEPS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Oct 2024 (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.
Improving pain and surgical field by using sphenopalatine ganglion block and dexmedetomidine in trans-nasal endoscopic pituitary surgery.
Detailed description
Pituitary neoplasm is one of the most common sellar pathology. Trans-nasal endoscopic pituitary surgery (TEPS) evolved rapidly, almost replacing the craniotomy approach. TEPS, a surgical instrument, is primarily executed through a minimally invasive approach through the nostril to access a pituitary tumor.
That is why the anesthetic plan must ensure the best possible surgical field visualization and the most adequate analgesia.
Multimodal anesthesia including regional and general anesthesia are obtained to optimize surgical field by decreasing bleeding, reduce pain, promote rapid recovery and potential economic gains for the hospital.
The sphenopalatine ganglion block (SPGB) is considered one of the regional anesthetic techniques that is safe and easy anesthetic procedure used to control bleeding and for postoperative analgesia.
Dexmedetomidine (DEX) has become popular for induced hypotension. It is an α2-adrenoceptor agonist with a sympatholytic and analgesic effect. It provides a unique conscious sedation without respiratory depression. It is used effectively in optimizing surgical field through its hemodynamic stability effect.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C (control group) (n=23) patients will be operated under general anesthesia. | Placebo comparator | Other: General Anesthesia (control group) |
| Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block | Active comparator | Procedure: Sphenopalatine Ganglion Block |
| Group DEX (n=23) patients will receive dexmedetomidine drug. | Active comparator | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: between 21-64 years old.
- sex: males and females.
- Body mass index: 35 kg/m2.
- ASA Physical status: grade Ⅰ-Ⅱ.
Key exclusion criteria (3 listed)
- patients receiving beta blockers, anti-coagulants and antihypertensive medications also patients receiving clonidine or benzodiazepines, neuroleptics or antidepressants two weeks prior to the study.
- Any contraindication for regional anesthesia e.g. coagulopathy, infection at site of block and hypersensitivity to any drug used in this study.
- Patients who are known to be drug addict.
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 Blockpatients will receive ultrasound guided bilateral supra-zygomatic sphenopalatine ganglion block. | Procedure or surgery | Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block |
| Dexmedetomidinepatients will receive 1 µg/kg dexmedetomidine within 10 minutes, followed by maintenance dose throughout the surgery. | Drug | Group DEX (n=23) patients will receive dexmedetomidine drug. |
| General Anesthesia (control group)patients will be operated under general anesthesia including routine protocol for these cases | Other | Group C (control group) (n=23) patients will be operated under general anesthesia. |
Primary outcome
Postoperative pain using VAS scale.
Time frame: 24hours
Pain will be assessed based on VAS scale from (1-10), as 1 is the least pain and 10 is the maximal pain possible at 2, 4, 6, 12 and 24h after surgery.
Surgical field using Average Category Scale (ACS).
Time frame: 5hours
Done by asking the surgeon about amount of bleeding on a scale of (0-5) as 0= no bleeding and 5= sever bleeding, every 15 min interval till the end of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Results publication: PubMed 33199256Anthony Cometa M, Zasimovich Y, Smith CR. Percutaneous sphenopalatine ganglion block: an alternative to the transnasal approach. Int J Obstet Anesth. 2021 Feb;45:163-164. doi: 10.1016/j.ijoa.2020.10.002. Epub 2020 Oct 17. No abstract available.
- Results publication: 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.
- Results publication: PubMed 33456810Hutton M, Brull R, Macfarlane AJR. Regional anaesthesia and outcomes. BJA Educ. 2018 Feb;18(2):52-56. doi: 10.1016/j.bjae.2017.10.002. Epub 2017 Nov 27. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dexmedetomidine in people with Sphenopalatine Ganglion Nerve Block and Transnasal Endoscopic Pitutary Surgery, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain using VAS scale. (time frame: 24hours). The study lists 2 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 NCT06639659, which also lists 3 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 2 Jan 2026.