Postoperative AnalgesiaNCT07345039
Infraorbital-Infratrochlear Block vs Sphenopalatine Ganglion Block for Postoperative Analgesia in Septorhinoplasty.
A study testing Infraorbital-Infratrochlear Nerve Block and Transnasal Sphenopalatine Ganglion Block in people with Postoperative Analgesia, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind clinical trial aims to compare the postoperative analgesic efficacy and recovery outcomes of infraorbital-infratrochlear nerve block and transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Infraorbital-Infratrochlear Nerve Block and Transnasal Sphenopalatine Ganglion Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2026to 31 Mar 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.
- Scheduled for septorhinoplasty under general anesthesia.
- American Society of Anesthesiologists (ASA) Physical Status I-II.
- Ability to cooperate with postoperative evaluations.
- Provision of written informed consent.
Who cannot join
- Allergy or contraindication to local anesthetics used in the study.
- Coagulopathy or anticoagulant therapy.
- Local infection at the nerve block application sites.
- Severe nasal anatomical abnormalities preventing transnasal block application.
- Psychiatric disorders affecting pain or agitation assessment..
- Chronic pain conditions or chronic opioid use.
- Neurological disorders affecting sensory perception.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, Turkey, 21070
About this study
Official title: Comparison of Infraorbital-Infratrochlear Nerve Block and Transnasal Sphenopalatine Ganglion Block on Postoperative Analgesia and Recovery Outcomes in Septorhinoplasty: A Prospective, Randomized, Double-Blind Clinical Trial
This prospective, randomized, double-blind clinical trial aims to compare the postoperative analgesic efficacy and recovery outcomes of infraorbital-infratrochlear nerve block and transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty under general anesthesia. Adult patients aged 18-65 years with ASA I-II status will be randomized to receive either bilateral infraorbital-infratrochlear block or transnasal sphenopalatine ganglion block after induction of anesthesia. Postoperative outcomes including pain scores (NRS at 0-2 h, 2-8 h, and 8-24 h), emergence agitation, Riker Sedation-Agitation Scale (RSAS) scores, time to first rescue analgesic, total tramadol consumption, adverse events, surgical site complications, and patient satisfaction will be assessed and compared between groups.
Read the detailed description
This study is designed to evaluate the postoperative analgesic efficacy and clinical outcomes of two regional anesthesia techniques-infraorbital-infratrochlear nerve block (ION-ITN block) and transnasal sphenopalatine ganglion block (usg guided sphenopalatine ganglion block,SPG block)-in patients undergoing septorhinoplasty under general anesthesia. Eligible patients aged 18-65 years with ASA physical status I-II will be randomly assigned to one of two intervention groups. Blocks will be performed after induction by an anesthesiologist not involved in postoperative assessment. Patients, surgeons, anesthesiologists performing postoperative evaluations, follow-up investigators, and data analysts will remain blinded to group allocation.
Postoperative outcomes will include pain intensity assessed using the Numerical Rating Scale (NRS) at 0-2, 2-8, and 8-24 hours after surgery, agitation between extubation and PACU discharge assessed with the Riker Sedation-Agitation Scale (RSAS), emergence agitation (RSAS ≥5), time to first rescue analgesic, and total tramadol consumption within 24 hours. Additional outcomes include postoperative nausea and vomiting, cardiovascular and respiratory adverse events, surgical site complications (edema, hematoma, neurologic deficit), and patient satisfaction measured by a 5-point Likert scale. Preoperative demographics, BMI, ASA class, comorbidities, anesthesia and surgery duration, and intraoperative remifentanil consumption will be recorded. The study aims to determine whether SPG block provides superior postoperative analgesia compared with ION-ITN block in septorhinoplasty patients.
- Conditions
- Postoperative Analgesia
- Being tested
- Infraorbital-Infratrochlear Nerve Block, Transnasal Sphenopalatine Ganglion Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraorbital-Infratrochlear Nerve BlockProcedure or surgery
Bilateral infraorbital and infratrochlear nerve block performed with 0.5% bupivacaine after induction of general anesthesia
Transnasal Sphenopalatine Ganglion BlockProcedure or surgery
Transnasal sphenopalatine ganglion block performed after induction of general anesthesia using local anesthetic-soaked applicators
| Study group | Role | What they receive |
|---|---|---|
| Infraorbital-Infratrochlear Nerve Block (ION-ITN Block) | Active comparator | Infraorbital-Infratrochlear Nerve Block (ION-ITN Block) Receives: Procedure: Infraorbital-Infratrochlear Nerve Block |
| Sphenopalatine Ganglion Block | Active comparator | Transnasal Sphenopalatine Ganglion Block (SPG Block) Receives: Procedure: Transnasal Sphenopalatine Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10) at three postoperative intervals: 0-2 hours, 2-8 hours, and 8-24 hours. Higher scores indicate greater pain.
Measured: 0-24 hours postoperative
Postoperative Agitation
Agitation severity assessed using the Riker Sedation-Agitation Scale (RSAS). The highest postoperative RSAS score is recorded. RSAS ≥5 is defined as emergence agitation.
Measured: Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)
Secondary outcomes (4)
Total Tramadol Consumption
Total amount of intravenous tramadol administered as postoperative analgesia.
Measured: First 24 hours postoperative
Incidence of Postoperative Nausea and Vomiting (PONV)
Occurrence of nausea or vomiting requiring treatment with ondansetron.
Measured: 0-24 hours postoperative
Adverse Events in PACU
Respiratory or cardiovascular events including oxygen desaturation, airway obstruction, hypotension, hypertension, or arrhythmia.
Measured: Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)
Patient Satisfaction Score
Patient satisfaction assessed using a 5-point Likert scale (1 = very unsatisfied, 5 = very satisfied).
Measured: At 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start16 Jan 2026
- Primary completion30 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, randomized and double-blind clinical trial comparing infraorbital-infratrochlear nerve block with transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345039
- Sponsor's protocol ID
- 12.2.2025-521
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Can E, Akkaya OT. A Comparison of Transnasal Versus Ultrasound-Guided Suprazygomatic Approaches for Sphenopalatine Ganglion Blocks in Persistent Idiopathic Facial Pain. Ann Indian Acad Neurol. 2025 Mar 1;28(2):189-195. doi: 10.4103/aian.aian_713_24. Epub 2025 Mar 13.
PubMed 40087987
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Infraorbital-Infratrochlear Nerve Block and Transnasal Sphenopalatine Ganglion Block on Postoperative Analgesia and Recovery Outcomes in Septorhinoplasty: A Prospective, Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07345039
- Acronym / sponsor ID
- 12.2.2025-521
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 15 Jan 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 prospective, randomized, double-blind clinical trial aims to compare the postoperative analgesic efficacy and recovery outcomes of infraorbital-infratrochlear nerve block and transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty under general anesthesia. Adult patients aged 18-65 years with ASA I-II status will be randomized to receive either bilateral infraorbital-infratrochlear block or transnasal sphenopalatine ganglion block after induction of anesthesia. Postoperative outcomes including pain scores (NRS at 0-2 h, 2-8 h, and 8-24 h), emergence agitation, Riker Sedation-Agitation Scale (RSAS) scores, time to first rescue analgesic, total tramadol consumption, adverse events, surgical site complications, and patient satisfaction will be assessed and compared between groups.
Detailed description
This study is designed to evaluate the postoperative analgesic efficacy and clinical outcomes of two regional anesthesia techniques-infraorbital-infratrochlear nerve block (ION-ITN block) and transnasal sphenopalatine ganglion block (usg guided sphenopalatine ganglion block,SPG block)-in patients undergoing septorhinoplasty under general anesthesia. Eligible patients aged 18-65 years with ASA physical status I-II will be randomly assigned to one of two intervention groups. Blocks will be performed after induction by an anesthesiologist not involved in postoperative assessment. Patients, surgeons, anesthesiologists performing postoperative evaluations, follow-up investigators, and data analysts will remain blinded to group allocation.
Postoperative outcomes will include pain intensity assessed using the Numerical Rating Scale (NRS) at 0-2, 2-8, and 8-24 hours after surgery, agitation between extubation and PACU discharge assessed with the Riker Sedation-Agitation Scale (RSAS), emergence agitation (RSAS ≥5), time to first rescue analgesic, and total tramadol consumption within 24 hours. Additional outcomes include postoperative nausea and vomiting, cardiovascular and respiratory adverse events, surgical site complications (edema, hematoma, neurologic deficit), and patient satisfaction measured by a 5-point Likert scale. Preoperative demographics, BMI, ASA class, comorbidities, anesthesia and surgery duration, and intraoperative remifentanil consumption will be recorded. The study aims to determine whether SPG block provides superior postoperative analgesia compared with ION-ITN block in septorhinoplasty patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, randomized and double-blind clinical trial comparing infraorbital-infratrochlear nerve block with transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty.
| Arm | Type | Receives |
|---|---|---|
| Infraorbital-Infratrochlear Nerve Block (ION-ITN Block) | Active comparator | Procedure: Infraorbital-Infratrochlear Nerve BlockInfraorbital-Infratrochlear Nerve Block (ION-ITN Block) |
| Sphenopalatine Ganglion Block | Active comparator | Procedure: Transnasal Sphenopalatine Ganglion BlockTransnasal Sphenopalatine Ganglion Block (SPG Block) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-65 years.
- Scheduled for septorhinoplasty under general anesthesia.
- American Society of Anesthesiologists (ASA) Physical Status I-II.
- Ability to cooperate with postoperative evaluations.
- Provision of written informed consent.
Key exclusion criteria (8 listed)
- Allergy or contraindication to local anesthetics used in the study.
- Coagulopathy or anticoagulant therapy.
- Local infection at the nerve block application sites.
- Severe nasal anatomical abnormalities preventing transnasal block application.
- Psychiatric disorders affecting pain or agitation assessment..
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 |
|---|---|---|
| Infraorbital-Infratrochlear Nerve BlockBilateral infraorbital and infratrochlear nerve block performed with 0.5% bupivacaine after induction of general anesthesia | Procedure or surgery | Infraorbital-Infratrochlear Nerve Block (ION-ITN Block) |
| Transnasal Sphenopalatine Ganglion BlockTransnasal sphenopalatine ganglion block performed after induction of general anesthesia using local anesthetic-soaked applicators | Procedure or surgery | Sphenopalatine Ganglion Block |
Primary outcome
Postoperative Pain Intensity
Time frame: 0-24 hours postoperative
Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10) at three postoperative intervals: 0-2 hours, 2-8 hours, and 8-24 hours. Higher scores indicate greater pain.
Postoperative Agitation
Time frame: Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)
Agitation severity assessed using the Riker Sedation-Agitation Scale (RSAS). The highest postoperative RSAS score is recorded. RSAS ≥5 is defined as emergence agitation.
4 secondary outcomes
Total Tramadol Consumption
Time frame: First 24 hours postoperative
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: 0-24 hours postoperative
Adverse Events in PACU
Time frame: Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)
Patient Satisfaction Score
Time frame: At 24 hours postoperative
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 1 Apr 2026.
- Background: PubMed 40087987Can E, Akkaya OT. A Comparison of Transnasal Versus Ultrasound-Guided Suprazygomatic Approaches for Sphenopalatine Ganglion Blocks in Persistent Idiopathic Facial Pain. Ann Indian Acad Neurol. 2025 Mar 1;28(2):189-195. doi: 10.4103/aian.aian_713_24. Epub 2025 Mar 13.
- 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 Infraorbital-Infratrochlear Nerve Block and Transnasal Sphenopalatine Ganglion Block in people with Postoperative Analgesia, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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 1 Apr 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 Turkey (Türkiye). 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?
Postoperative Pain Intensity (time frame: 0-24 hours postoperative). 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 NCT07345039, which also lists 1 linked publication.
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 1 Apr 2026.