UltrasoundNCT06984913
Ultrasound-Guided Versus Brainlab Navigation Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery
A study testing Ultrasound-guided sphenopalatine ganglion block, Brainlab navigation sphenopalatine ganglion block and Low dose Brainlab navigation sphenopalatine ganglion block in people with Ultrasound and Brainlab Navigation, run by Tanta University at 1 site in Egypt.
Trial summary
This study compares ultrasound-guided and Brainlab navigation sphenopalatine ganglion block (SPGB) in functional endoscopic sinus surgery (FESS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ultrasound, Brainlab Navigation, Sphenopalatine Ganglion Block
- What is being tested?
- Ultrasound-guided sphenopalatine ganglion block, Brainlab navigation sphenopalatine ganglion block and Low dose Brainlab navigation sphenopalatine ganglion block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 May 2025to 16 Oct 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients undergoing functional endoscopic sinus surgery under general anesthesia.
Who cannot join
- Patients having a history of severe renal, hepatic, respiratory, cardiac disease, or a neurological condition.
- Drug or alcohol abuse.
- Chronic pain requires major analgesics, sedatives, or corticosteroids.
- Pregnant and lactating women.
- Hypersensitivity to local anesthetic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Versus Brainlab Navigation Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery: A Randomized Clinical Trial
This study compares ultrasound-guided and Brainlab navigation sphenopalatine ganglion block (SPGB) in functional endoscopic sinus surgery (FESS).
Read the detailed description
Functional endoscopic sinus surgery (FESS) is the treatment modality of choice for the inflammatory disease of paranasal sinuses.
Sphenopalatine ganglion block (SPGB) is a regional analgesic technique that can be used as an alternative approach to reduce blood loss and improve the operative field during FESS without the need for hypotensive agents.
Ultrasound (US)-guided nerve block is a well-established technique in regional anesthesia and offers the advantage of real-time visualization of neural and vascular structures.
- Conditions
- Ultrasound, Brainlab Navigation, Sphenopalatine Ganglion Block, Functional Endoscopic Sinus Surgery
- Being tested
- Ultrasound-guided sphenopalatine ganglion block, Brainlab navigation sphenopalatine ganglion block, Low dose Brainlab navigation sphenopalatine ganglion block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided sphenopalatine ganglion blockOther
Patients will receive an ultrasound-guided sphenopalatine ganglion block (4 ml bupivacaine 0.25%).
Brainlab navigation sphenopalatine ganglion blockOther
Patients will receive a Brainlab navigation sphenopalatine ganglion block (4 ml bupivacaine 0.25%).
Low dose Brainlab navigation sphenopalatine ganglion blockOther
Patients will receive a Brainlab navigation sphenopalatine ganglion block (2 ml bupivacaine 0.25%) (low dose).
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | Experimental | Patients will receive an ultrasound-guided sphenopalatine ganglion block (4 ml bupivacaine 0.25%). Receives: Other: Ultrasound-guided sphenopalatine ganglion block |
| Brainlab group | Experimental | Patients will receive a Brainlab navigation sphenopalatine ganglion block (4 ml bupivacaine 0.25%). Receives: Other: Brainlab navigation sphenopalatine ganglion block |
| Low dose Brainlab group | Experimental | Patients will receive a Brainlab navigation sphenopalatine ganglion block (2 ml bupivacaine 0.25%) (low dose). Receives: Other: Low dose Brainlab navigation sphenopalatine ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical field condition
The Fromme-Boezaart scale (6-point scale) will be used to assess the endoscopic surgical field condition after GA induction, at the entrance of the endoscope, and after 15, 30, 45, 60, 75, 90, 105, 120, and 135 min.
0=No bleeding (cadaveric conditions).
- Slight bleeding, no suctioning required.
- Slight bleeding, occasional suctioning required.
- Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed.
- Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed.
- Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened, and surgery usually not possible.
Measured: 135 min post-procedure
Secondary outcomes (8)
Mean arterial pressure
Mean arterial pressure will be recorded after induction of general anesthesia, at entrance of endoscope, after 15, 30, 45, 60, 75, 90, 105, 120, and 135 min.
Measured: 135 min post-procedure
Heart rate
Heart rate will be recorded after induction of general anesthesia, at the entrance of the endoscope, after 15, 30, 45, 60, 75, 90, 105, 120, and 135 min.
Measured: 135 min post-procedure
Intraoperative fentanyl consumption
To improve the conditions of the surgical field, hemodynamics will be managed (A fixed target of mean blood pressure around 65 mmHg should be obtained) using these medications in the following order fentanyl 0.5 ug/kg.
Measured: Intraoperatively
Intraoperative nitroglycerine consumption
Intraoperative requirements of nitroglycerine will be calculated.
Measured: Intraoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS: will be assessed at 0, 4, 8, 12, and 24 h postoperatively
Measured: 24 hours postoperatively
Time to extubation
Time to extubation: the time from discontinuing anesthesia to fulfilling extubation criteria will be recorded.
Measured: One hour postoperatively
Recovery time
Recovery time: the time from extubation, till patients attain an Aldrete score >9, will be recorded.
Measured: One hour postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start22 May 2025
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ismail Sharaf, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984913
- Sponsor's protocol ID
- 36264PR1183/4/25
- Status last verified
- Nov 2025
- First submitted
- 14 May 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Versus Brainlab Navigation Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06984913
- Acronym / sponsor ID
- 36264PR1183/4/25
- Conditions
- Ultrasound, Brainlab Navigation, Sphenopalatine Ganglion Block, Functional Endoscopic Sinus Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 22 May 2025 (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.
This study compares ultrasound-guided and Brainlab navigation sphenopalatine ganglion block (SPGB) in functional endoscopic sinus surgery (FESS).
Detailed description
Functional endoscopic sinus surgery (FESS) is the treatment modality of choice for the inflammatory disease of paranasal sinuses.
Sphenopalatine ganglion block (SPGB) is a regional analgesic technique that can be used as an alternative approach to reduce blood loss and improve the operative field during FESS without the need for hypotensive agents.
Ultrasound (US)-guided nerve block is a well-established technique in regional anesthesia and offers the advantage of real-time visualization of neural and vascular structures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Experimental | Other: Ultrasound-guided sphenopalatine ganglion blockPatients will receive an ultrasound-guided sphenopalatine ganglion block (4 ml bupivacaine 0.25%). |
| Brainlab group | Experimental | Other: Brainlab navigation sphenopalatine ganglion blockPatients will receive a Brainlab navigation sphenopalatine ganglion block (4 ml bupivacaine 0.25%). |
| Low dose Brainlab group | Experimental | Other: Low dose Brainlab navigation sphenopalatine ganglion blockPatients will receive a Brainlab navigation sphenopalatine ganglion block (2 ml bupivacaine 0.25%) (low dose). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients undergoing functional endoscopic sinus surgery under general anesthesia.
Key exclusion criteria (5 listed)
- Patients having a history of severe renal, hepatic, respiratory, cardiac disease, or a neurological condition.
- Drug or alcohol abuse.
- Chronic pain requires major analgesics, sedatives, or corticosteroids.
- Pregnant and lactating women.
- Hypersensitivity to local anesthetic agents.
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 |
|---|---|---|
| Ultrasound-guided sphenopalatine ganglion blockPatients will receive an ultrasound-guided sphenopalatine ganglion block (4 ml bupivacaine 0.25%). | Other | Ultrasound group |
| Brainlab navigation sphenopalatine ganglion blockPatients will receive a Brainlab navigation sphenopalatine ganglion block (4 ml bupivacaine 0.25%). | Other | Brainlab group |
| Low dose Brainlab navigation sphenopalatine ganglion blockPatients will receive a Brainlab navigation sphenopalatine ganglion block (2 ml bupivacaine 0.25%) (low dose). | Other | Low dose Brainlab group |
Primary outcome
Surgical field condition
Time frame: 135 min post-procedure
The Fromme-Boezaart scale (6-point scale) will be used to assess the endoscopic surgical field condition after GA induction, at the entrance of the endoscope, and after 15, 30, 45, 60, 75, 90, 105, 120, and 135 min. 0=No bleeding (cadaveric conditions). 1. Slight bleeding, no suctioning required. 2. Slight bleeding, occasional suctioning required. 3. Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed. 4. Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed. 5. Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened, and surgery usually not possible.
8 secondary outcomes
Mean arterial pressure
Time frame: 135 min post-procedure
Heart rate
Time frame: 135 min post-procedure
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Intraoperative nitroglycerine consumption
Time frame: Intraoperatively
Degree of pain
Time frame: 24 hours postoperatively
Time to extubation
Time frame: One hour postoperatively
Recovery time
Time frame: One hour postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Ultrasound-guided sphenopalatine ganglion block, Brainlab navigation sphenopalatine ganglion block and Low dose Brainlab navigation sphenopalatine ganglion block in people with Ultrasound and Brainlab Navigation, run by Tanta 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 5 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: finished, as of the sponsor's last update on 25 Nov 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surgical field condition (time frame: 135 min post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025.