Quality of Recovery (QoR-15)NCT06929429
Effect of Bilateral SPG and Infraorbital Nerve Blocks on Recovery After Septorhinoplasty
A study testing Bilateral Sphenopalatine Ganglion Block and Bilateral Infraorbital Nerve Block in people with Quality of Recovery (QoR-15) and Sphenopalatine Ganglion Block, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind controlled study aims to compare the effects of bilateral sphenopalatine ganglion and infraorbital nerve blocks on postoperative recovery quality in patients undergoing elective septorhinoplasty under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Recovery (QoR-15), Sphenopalatine Ganglion Block, Infraorbital Nerve Block
- What is being tested?
- Bilateral Sphenopalatine Ganglion Block and Bilateral Infraorbital Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2025to 29 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
- Adults aged 18-65 years
- Scheduled for elective septorhinoplasty under general anesthesia
- ASA physical status I-II
- Able to understand and sign informed consent
Who cannot join
- Local infection at the injection site
- History of psychiatric or neurological disorders that impair questionnaire response
- Known coagulopathy
- Allergy to local anesthetics
- History of chronic pain or use of chronic analgesic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Bilateral Sphenopalatine Ganglion and Infraorbital Nerve Blocks on Postoperative Recovery in Patients Undergoing Septorhinoplasty: A Prospective, Randomized, Double-Blind, Controlled Study"
This prospective, randomized, double-blind controlled study aims to compare the effects of bilateral sphenopalatine ganglion and infraorbital nerve blocks on postoperative recovery quality in patients undergoing elective septorhinoplasty under general anesthesia. A total of 90 adult patients (aged 18-65, ASA I-II) will be randomly assigned into two groups: Group 1 will receive bilateral sphenopalatine ganglion block, and Group 2 will receive bilateral infraorbital nerve block. Both blocks will be performed using 4 mL of 0.5% bupivacaine.
The primary outcome is the quality of recovery assessed 24 hours after surgery using the QoR-15 questionnaire. Secondary outcomes include intraoperative anesthetic consumption (propofol, remifentanil), emergence agitation (RASS scale), postoperative pain (VAS), need for rescue analgesics (morphine), postoperative nausea and vomiting (VDS), antiemetic consumption (ondansetron), facial edema and hematoma, and length of stay in the post-anesthesia care unit (PACU).
All procedures will follow standardized general anesthesia protocols. The study aims to determine which block technique provides superior postoperative recovery, better pain control, fewer side effects, and higher patient satisfaction. No placebo will be used, and no biological samples will be collected.
Read the detailed description
This study is a prospective, randomized, double-blind, controlled clinical trial designed to evaluate the effects of two regional anesthesia techniques-bilateral sphenopalatine ganglion block and bilateral infraorbital nerve block-on postoperative recovery quality in adult patients undergoing elective septorhinoplasty under general anesthesia.
A total of 90 patients aged 18-65 years, classified as ASA physical status I-II, will be randomly assigned into two groups using sealed opaque envelope randomization by a non-involved healthcare provider. Group 1 (n=45) will receive bilateral sphenopalatine ganglion blocks with 4 mL of 0.5% bupivacaine applied intranasally using cotton-tipped applicators. Group 2 (n=45) will receive bilateral infraorbital nerve blocks with 4 mL of 0.5% bupivacaine under ultrasound guidance. Both blocks will be performed after anesthesia induction but before the start of surgery.
All patients will undergo standardized general anesthesia using propofol, fentanyl, and rocuronium for induction, followed by maintenance with remifentanil infusion and propofol titration to maintain BIS 40-60. Analgesic medications such as paracetamol, dexketoprofen, and dexamethasone will be administered intraoperatively. At the end of surgery, neuromuscular blockade will be reversed with sugammadex, and patients will be extubated when the TOF ratio exceeds 0.9.
Postoperative assessments include pain severity using the Visual Analog Scale (VAS), agitation level using the Richmond Agitation-Sedation Scale (RASS), and postoperative nausea and vomiting (PONV) using the Verbal Descriptive Scale (VDS). Rescue analgesia (morphine) and antiemetic (ondansetron) use will be recorded. The primary outcome is the quality of recovery measured by the QoR-15 questionnaire at 24 hours postoperatively. Secondary outcomes include intraoperative anesthetic consumption, total opioid requirement within 24 hours, time to first analgesic use, facial edema/hematoma, and PACU discharge time using the Modified Aldrete Score.
All interventions and assessments will be performed by blinded observers, and no placebo or experimental drugs will be used. No biological specimens will be collected.
- Being tested
- Bilateral Sphenopalatine Ganglion Block, Bilateral Infraorbital Nerve Block
- Keywords
- Septorhinoplasty, Quality of Recovery, Regional Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Sphenopalatine Ganglion BlockProcedure or surgery
A bilateral sphenopalatine ganglion block will be performed after induction of general anesthesia using 4 mL of 0.5% bupivacaine. The local anesthetic will be applied intranasally with a cotton-tipped applicator placed parallel to the zygomatic arch and advanced to the posterior nasal cavity. The applicator will remain in place for 15 minutes.
Bilateral Infraorbital Nerve BlockProcedure or surgery
A bilateral infraorbital nerve block will be performed after induction of general anesthesia using 4 mL of 0.5% bupivacaine per side. The block will be guided by linear ultrasound to identify the infraorbital foramen and administered with a 22G needle around the nerve. A 15-minute absorption period will be allowed before the surgical procedure begins.
| Study group | Role | What they receive |
|---|---|---|
| Sphenopalatine ganglion block | Active comparator | Participants in this group will receive a bilateral sphenopalatine ganglion block using 4 mL of 0.5% bupivacaine via intranasal application after induction of general anesthesia and before the start of surgery. Receives: Procedure: Bilateral Sphenopalatine Ganglion Block |
| Infraorbital Nerve Block | Active comparator | Participants in this group will receive a bilateral infraorbital nerve block with 4 mL of 0.5% bupivacaine administered under ultrasound guidance after induction of general anesthesia and before the start of surgery. Receives: Procedure: Bilateral Infraorbital Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery at postoperative 24 hours
Postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The scale contains 15 items covering pain, physical comfort, emotional state, physical independence, and psychological support. Each item is scored from 0 to 10, and the total score ranges from 0 to 150. Higher scores indicate better recovery.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Pain severity over 24 hours
Postoperative pain intensity will be measured using the Visual Analog Scale (VAS) at 1, 2, 6, 12, and 24 hours. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
Measured: 1 to 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 posted16 Apr 2025
- Study start19 Jun 2025
- Primary completion29 Apr 2026
- Study completion29 Apr 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 Quality of Recovery (QoR-15)Studies 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
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive either a bilateral sphenopalatine ganglion block or a bilateral infraorbital nerve block. Each participant will receive only one type of intervention, and the outcomes will be compared between the two groups.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Keklicek, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929429
- Sponsor's protocol ID
- 2025/23
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keklicek O, Aydemir M, Atay T, Koc MN, Goger E, Tutar MS, Kozanhan B, Aydemir F. Infraorbital versus sphenopalatine ganglion block for patient-reported recovery after septorhinoplasty: A randomized controlled trial. J Clin Anesth. 2026 Oct 28;116:112354. doi: 10.1016/j.jclinane.2026.112354. Online ahead of print.
PubMed 42950360
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Bilateral Sphenopalatine Ganglion and Infraorbital Nerve Blocks on Postoperative Recovery in Patients Undergoing Septorhinoplasty: A Prospective, Randomized, Double-Blind, Controlled Study"
- ClinicalTrials.gov ID
- NCT06929429
- Acronym / sponsor ID
- 2025/23
- Keywords
- Septorhinoplasty, Quality of Recovery, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 16 Apr 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 prospective, randomized, double-blind controlled study aims to compare the effects of bilateral sphenopalatine ganglion and infraorbital nerve blocks on postoperative recovery quality in patients undergoing elective septorhinoplasty under general anesthesia. A total of 90 adult patients (aged 18-65, ASA I-II) will be randomly assigned into two groups: Group 1 will receive bilateral sphenopalatine ganglion block, and Group 2 will receive bilateral infraorbital nerve block. Both blocks will be performed using 4 mL of 0.5% bupivacaine.
The primary outcome is the quality of recovery assessed 24 hours after surgery using the QoR-15 questionnaire. Secondary outcomes include intraoperative anesthetic consumption (propofol, remifentanil), emergence agitation (RASS scale), postoperative pain (VAS), need for rescue analgesics (morphine), postoperative nausea and vomiting (VDS), antiemetic consumption (ondansetron), facial edema and hematoma, and length of stay in the post-anesthesia care unit (PACU).
All procedures will follow standardized general anesthesia protocols. The study aims to determine which block technique provides superior postoperative recovery, better pain control, fewer side effects, and higher patient satisfaction. No placebo will be used, and no biological samples will be collected.
Detailed description
This study is a prospective, randomized, double-blind, controlled clinical trial designed to evaluate the effects of two regional anesthesia techniques-bilateral sphenopalatine ganglion block and bilateral infraorbital nerve block-on postoperative recovery quality in adult patients undergoing elective septorhinoplasty under general anesthesia.
A total of 90 patients aged 18-65 years, classified as ASA physical status I-II, will be randomly assigned into two groups using sealed opaque envelope randomization by a non-involved healthcare provider. Group 1 (n=45) will receive bilateral sphenopalatine ganglion blocks with 4 mL of 0.5% bupivacaine applied intranasally using cotton-tipped applicators. Group 2 (n=45) will receive bilateral infraorbital nerve blocks with 4 mL of 0.5% bupivacaine under ultrasound guidance. Both blocks will be performed after anesthesia induction but before the start of surgery.
All patients will undergo standardized general anesthesia using propofol, fentanyl, and rocuronium for induction, followed by maintenance with remifentanil infusion and propofol titration to maintain BIS 40-60. Analgesic medications such as paracetamol, dexketoprofen, and dexamethasone will be administered intraoperatively. At the end of surgery, neuromuscular blockade will be reversed with sugammadex, and patients will be extubated when the TOF ratio exceeds 0.9.
Postoperative assessments include pain severity using the Visual Analog Scale (VAS), agitation level using the Richmond Agitation-Sedation Scale (RASS), and postoperative nausea and vomiting (PONV) using the Verbal Descriptive Scale (VDS). Rescue analgesia (morphine) and antiemetic (ondansetron) use will be recorded. The primary outcome is the quality of recovery measured by the QoR-15 questionnaire at 24 hours postoperatively. Secondary outcomes include intraoperative anesthetic consumption, total opioid requirement within 24 hours, time to first analgesic use, facial edema/hematoma, and PACU discharge time using the Modified Aldrete Score.
All interventions and assessments will be performed by blinded observers, and no placebo or experimental drugs will be used. No biological specimens will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive either a bilateral sphenopalatine ganglion block or a bilateral infraorbital nerve block. Each participant will receive only one type of intervention, and the outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Sphenopalatine ganglion block | Active comparator | Procedure: Bilateral Sphenopalatine Ganglion BlockParticipants in this group will receive a bilateral sphenopalatine ganglion block using 4 mL of 0.5% bupivacaine via intranasal application after induction of general anesthesia and before the start of surgery. |
| Infraorbital Nerve Block | Active comparator | Procedure: Bilateral Infraorbital Nerve BlockParticipants in this group will receive a bilateral infraorbital nerve block with 4 mL of 0.5% bupivacaine administered under ultrasound guidance after induction of general anesthesia and before the start of surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-65 years
- Scheduled for elective septorhinoplasty under general anesthesia
- ASA physical status I-II
- Able to understand and sign informed consent
Key exclusion criteria (5 listed)
- Local infection at the injection site
- History of psychiatric or neurological disorders that impair questionnaire response
- Known coagulopathy
- Allergy to local anesthetics
- History of chronic pain or use of chronic analgesic medication
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 Sphenopalatine Ganglion BlockA bilateral sphenopalatine ganglion block will be performed after induction of general anesthesia using 4 mL of 0.5% bupivacaine. The local anesthetic will be applied intranasally with a cotton-tipped applicator placed parallel to the zygomatic arch and advanced to the posterior nasal cavity. The applicator will remain in place for 15 minutes. | Procedure or surgery | Sphenopalatine ganglion block |
| Bilateral Infraorbital Nerve BlockA bilateral infraorbital nerve block will be performed after induction of general anesthesia using 4 mL of 0.5% bupivacaine per side. The block will be guided by linear ultrasound to identify the infraorbital foramen and administered with a 22G needle around the nerve. A 15-minute absorption period will be allowed before the surgical procedure begins. | Procedure or surgery | Infraorbital Nerve Block |
Primary outcome
Quality of recovery at postoperative 24 hours
Time frame: 24 hours postoperatively
Postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The scale contains 15 items covering pain, physical comfort, emotional state, physical independence, and psychological support. Each item is scored from 0 to 10, and the total score ranges from 0 to 150. Higher scores indicate better recovery.
1 secondary outcome
Pain severity over 24 hours
Time frame: 1 to 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 6 May 2026.
- Derived from this study: PubMed 42950360Keklicek O, Aydemir M, Atay T, Koc MN, Goger E, Tutar MS, Kozanhan B, Aydemir F. Infraorbital versus sphenopalatine ganglion block for patient-reported recovery after septorhinoplasty: A randomized controlled trial. J Clin Anesth. 2026 Oct 28;116:112354. doi: 10.1016/j.jclinane.2026.112354. Online ahead of print.
- 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.
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 Bilateral Sphenopalatine Ganglion Block and Bilateral Infraorbital Nerve Block in people with Quality of Recovery (QoR-15) and Sphenopalatine Ganglion Block, run by Konya City 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 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 6 May 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?
Quality of recovery at postoperative 24 hours (time frame: 24 hours postoperatively). 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 NCT06929429, 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 6 May 2026.