Chronic Rhinosinusitis (CRS)SPGB-EANCT07645521
Trans-nasal Sphenopalatine Ganglion Block for Prevention of Emergence Agitation Following Functional Endoscopic Sinus Surgery
A study testing Bilateral Trans-nasal Sphenopalatine Ganglion Block in people with Chronic Rhinosinusitis (CRS) and Emergence Agitation, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized double-blind controlled trial aims to evaluate whether bilateral trans-nasal sphenopalatine ganglion block (SPGB) using bupivacaine reduces the incidence of emergence agitation following Functional Endoscopic Sinus Surgery (FESS) compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis (CRS), Emergence Agitation
- What is being tested?
- Bilateral Trans-nasal Sphenopalatine Ganglion Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2025to 13 Apr 2026
- 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 18-65 years.
- ASA physical status I-II.
- Scheduled for elective FESS under general anesthesia.
- Ability to provide informed consent. Exclusion Criteria
- ASA physical status III or higher.
- Known allergy or contraindication to local anesthetics.
Show all 12Show fewer
- Coagulopathy or anticoagulant therapy.
- Psychiatric illness or cognitive impairment affecting agitation assessment.
- Chronic opioid use or substance abuse.
- Pregnancy or lactation.
- Revision nasal surgery or anatomical abnormalities preventing SPGB.
- Intraoperative complications requiring deviation from the study protocol.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bilateral Trans-nasal Sphenopalatine Ganglion Block on Emergence Agitation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial
This randomized double-blind controlled trial aims to evaluate whether bilateral trans-nasal sphenopalatine ganglion block (SPGB) using bupivacaine reduces the incidence of emergence agitation following Functional Endoscopic Sinus Surgery (FESS) compared with placebo. Secondary objectives include evaluation of postoperative pain, postoperative opioid consumption, hemodynamic parameters, postoperative nausea and vomiting, and adverse events.
- Conditions
- Chronic Rhinosinusitis (CRS), Emergence Agitation
- Being tested
- Bilateral Trans-nasal Sphenopalatine Ganglion Block, Sham Trans-nasal Injection
- Keywords
- Functional Endoscopic Sinus Surgery, FESS, Sphenopalatine Ganglion Block, SPGB, Trans-nasal Sphenopalatine Ganglion Block, Emergence Agitation, Randomized Controlled Trial, Postoperative Pain, Sinonasal Surgery
- Medical subject headings
- Emergence Delirium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Trans-nasal Sphenopalatine Ganglion BlockProcedure or surgery
Also called Endoscopic Sphenopalatine Ganglion Block, SPGB
Bilateral trans-nasal sphenopalatine ganglion block performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side.
Sham Trans-nasal InjectionProcedure or surgery
Also called Placebo Injection, Sham Procedure, Sham Sphenopalatine Ganglion Block
Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL of normal saline per side.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (SPGB) | Experimental | Bilateral trans-nasal SPGB performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side. Receives: Procedure: Bilateral Trans-nasal Sphenopalatine Ganglion Block |
| Placebo Comparator Group (C) | Placebo comparator | Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL normal saline per side. Receives: Procedure: Sham Trans-nasal Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Emergence Agitation
Incidence of emergence agitation, defined as a Richmond Agitation-Sedation Scale (RASS) score ≥ +2 at any time during the first 30 minutes in the post-anesthesia care unit (PACU).
Measured: first 30 minutes in the post-anesthesia care unit (PACU).
Secondary outcomes (7)
Postoperative Pain Scores
Pain intensity assessed using the Visual Analog Scale (VAS).
Measured: first 30 minutes in the post-anesthesia care unit (PACU)
Postoperative Fentanyl Consumption
Total postoperative fentanyl requirement administered for rescue analgesia.
Measured: first 30 minutes in the post-anesthesia care unit (PACU)
Mean Arterial Blood Pressure
Intraoperative and postoperative mean arterial blood pressure measurements.
Measured: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Heart Rate
Intraoperative and postoperative heart rate measurements.
Measured: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Incidence of Postoperative Nausea and Vomiting
Occurrence of postoperative nausea and/or vomiting.
Measured: first 30 minutes in the post-anesthesia care unit (PACU)
Adverse Events
Procedure-related complications including epistaxis, local anesthetic systemic toxicity, diplopia or visual symptoms, palatal numbness, and other adverse events.
Measured: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Duration of Surgery
Total operative time measured from surgical incision to completion of surgery.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start5 Jan 2025
- Primary completion7 Feb 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (CRS)Studies of the same condition, open and under way.
- More trials run by Mansoura 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Mostafa Shabana, MD, Principal investigator, Faculty of Medicine, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645521
- Sponsor's protocol ID
- ANES-FESS-SPGB-2026-01
- Acronym
- SPGB-EA
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8.
PubMed 21739090Wang P. The efficacy of sphenopalatine ganglion block for pain management after endoscopic sinus surgery: a meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2021 Aug;278(8):2681-2687. doi: 10.1007/s00405-020-06484-9. Epub 2021 Jan 3.
PubMed 33388988Kim DH, Kang H, Hwang SH. The Effect of Sphenopalatine Block on the Postoperative Pain of Endoscopic Sinus Surgery: A Meta-analysis. Otolaryngol Head Neck Surg. 2019 Feb;160(2):223-231. doi: 10.1177/0194599818805673. Epub 2018 Oct 9.
PubMed 30296912Hamed R, Gamal L, Elsawy S, Baker MA, Abbas YH. Efficacy of ultrasound guided sphenopalatine ganglion block in management of emergence agitation after sinoscopic nasal surgery: a randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101429. doi: 10.1016/j.accpm.2024.101429. Epub 2024 Oct 2.
PubMed 39366653
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Trans-nasal Sphenopalatine Ganglion Block on Emergence Agitation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07645521
- Acronym / sponsor ID
- SPGB-EA / ANES-FESS-SPGB-2026-01
- Conditions
- Chronic Rhinosinusitis (CRS), Emergence Agitation
- Keywords
- Functional Endoscopic Sinus Surgery, FESS, Sphenopalatine Ganglion Block, SPGB, Trans-nasal Sphenopalatine Ganglion Block, Emergence Agitation, Randomized Controlled Trial, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 7 Feb 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 12 Jun 2026 (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 randomized double-blind controlled trial aims to evaluate whether bilateral trans-nasal sphenopalatine ganglion block (SPGB) using bupivacaine reduces the incidence of emergence agitation following Functional Endoscopic Sinus Surgery (FESS) compared with placebo. Secondary objectives include evaluation of postoperative pain, postoperative opioid consumption, hemodynamic parameters, postoperative nausea and vomiting, and adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (SPGB) | Experimental | Procedure: Bilateral Trans-nasal Sphenopalatine Ganglion BlockBilateral trans-nasal SPGB performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side. |
| Placebo Comparator Group (C) | Placebo comparator | Procedure: Sham Trans-nasal InjectionBilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL normal saline per side. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-65 years.
- ASA physical status I-II.
- Scheduled for elective FESS under general anesthesia.
- Ability to provide informed consent. Exclusion Criteria
- ASA physical status III or higher.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bilateral Trans-nasal Sphenopalatine Ganglion BlockAlso: Endoscopic Sphenopalatine Ganglion Block, SPGBBilateral trans-nasal sphenopalatine ganglion block performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side. | Procedure or surgery | Experimental Group (SPGB) |
| Sham Trans-nasal InjectionAlso: Placebo Injection, Sham Procedure, Sham Sphenopalatine Ganglion BlockBilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL of normal saline per side. | Procedure or surgery | Placebo Comparator Group (C) |
Primary outcome
Incidence of Emergence Agitation
Time frame: first 30 minutes in the post-anesthesia care unit (PACU).
Incidence of emergence agitation, defined as a Richmond Agitation-Sedation Scale (RASS) score ≥ +2 at any time during the first 30 minutes in the post-anesthesia care unit (PACU).
7 secondary outcomes
Postoperative Pain Scores
Time frame: first 30 minutes in the post-anesthesia care unit (PACU)
Postoperative Fentanyl Consumption
Time frame: first 30 minutes in the post-anesthesia care unit (PACU)
Mean Arterial Blood Pressure
Time frame: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Heart Rate
Time frame: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Incidence of Postoperative Nausea and Vomiting
Time frame: first 30 minutes in the post-anesthesia care unit (PACU)
Adverse Events
Time frame: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Duration of Surgery
Time frame: During surgery
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 12 Jun 2026.
- Background: PubMed 21739090Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8.
- Background: PubMed 33388988Wang P. The efficacy of sphenopalatine ganglion block for pain management after endoscopic sinus surgery: a meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2021 Aug;278(8):2681-2687. doi: 10.1007/s00405-020-06484-9. Epub 2021 Jan 3.
- Background: PubMed 30296912Kim DH, Kang H, Hwang SH. The Effect of Sphenopalatine Block on the Postoperative Pain of Endoscopic Sinus Surgery: A Meta-analysis. Otolaryngol Head Neck Surg. 2019 Feb;160(2):223-231. doi: 10.1177/0194599818805673. Epub 2018 Oct 9.
- Background: PubMed 39366653Hamed R, Gamal L, Elsawy S, Baker MA, Abbas YH. Efficacy of ultrasound guided sphenopalatine ganglion block in management of emergence agitation after sinoscopic nasal surgery: a randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101429. doi: 10.1016/j.accpm.2024.101429. Epub 2024 Oct 2.
- 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.
Amir Mostafa Shabana, MD principal investigator
Faculty of Medicine, Mansoura University, Mansoura, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Trans-nasal Sphenopalatine Ganglion Block in people with Chronic Rhinosinusitis (CRS) and Emergence Agitation, run by Mansoura 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 12 inclusion and 0 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 12 Jun 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?
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?
Incidence of Emergence Agitation (time frame: first 30 minutes in the post-anesthesia care unit (PACU).). 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 NCT07645521, which also lists 4 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 12 Jun 2026.