SeptorhinoplastyNCT07608861
Effect of Bilateral Maxillary Block on Intraoperative Remifentanil Consumption
A study testing Preoperative Maxillary Block and Postoperative Maxillary Block in people with Septorhinoplasty and Remifentanil Consumption, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The maxillary nerve block is a regional anesthetic technique targeting the sensory distribution of the maxillary nerve and is particularly preferred to provide analgesia in midfacial and maxillary surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Septorhinoplasty, Remifentanil Consumption, Maxillary Block
- What is being tested?
- Preoperative Maxillary Block and Postoperative Maxillary Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 20 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II
- Body mass index 18 to 30 kg/m2
- Septorhinoplasty surgery
Who cannot join
- Patient refusing the procedure
- Patients who have previously undergone nasal surgery
- Chronic opioid or analgesic use
- Patients with allergies to local anesthetics
- Patients with Hypertension
- Patients receiving antihypertensive treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
Musa Zengin, Associate Professor, 00905307716235, musazengin@gmail.com
Mücahit Yılmaz, Medical Doctor, 00905366840479, dr.mucahitosman@gmail.com
About this study
Official title: Effect of Bilateral Maxillary Block on Intraoperative Remifentanil Consumption in Septorhinoplasty Surgery
The maxillary nerve block is a regional anesthetic technique targeting the sensory distribution of the maxillary nerve and is particularly preferred to provide analgesia in midfacial and maxillary surgical procedures. It has been used to optimize perioperative and postoperative pain control, reduce intraoperative opioid requirements, and support hemodynamic stability in procedures including septorhinoplasty, nasal bone osteotomies, nasal valve surgery, and endoscopic sinus surgery. This study aimed to compare the effects of the timing of bilateral maxillary nerve block administration (post-intubation vs. pre-extubation) on intraoperative remifentanil consumption and postoperative analgesia in patients undergoing septorhinoplasty.
- Conditions
- Septorhinoplasty, Remifentanil Consumption, Maxillary Block
- Being tested
- Preoperative Maxillary Block, Postoperative Maxillary Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Maxillary BlockDrug
After the intubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa. Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions. A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle. The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique. After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side. The same procedure will subsequently be repeated contralaterally.
Postoperative Maxillary BlockDrug
At the end of the surgery, before the extubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa. Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions. A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle. The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique. After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side. The same procedure will subsequently be repeated contralaterally.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Maxillary Block | Active comparator | After the intubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa. Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions. A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle. The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique. After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side. The same procedure will subsequently be repeated contralaterally. Receives: Drug: Preoperative Maxillary Block |
| Postoperative Maxillary Block | Active comparator | At the end of the surgery, before the extubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa. Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions. A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle. The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique. After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side. The same procedure will subsequently be repeated contralaterally. Receives: Drug: Postoperative Maxillary Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.
Measured: Intraoperative period
Secondary outcomes (3)
Mean arterial pressure
Mean arterial pressure values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th, 150th, 180th, and 210th minutes, and after general anesthesia.
Measured: Intraoperative period
Heart rate
Heart rate values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th, 150th, 180th, and 210th minutes, and after general anesthesia.
Measured: Intraoperative period
Pain scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st, 2nd, 6th, 12th, and 24th hours after surgery.
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeptorhinoplastyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608861
- Sponsor's protocol ID
- AEŞH-EK-32
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Maxillary Block on Intraoperative Remifentanil Consumption in Septorhinoplasty Surgery
- ClinicalTrials.gov ID
- NCT07608861
- Acronym / sponsor ID
- AEŞH-EK-32
- Conditions
- Septorhinoplasty, Remifentanil Consumption, Maxillary Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 27 May 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.
The maxillary nerve block is a regional anesthetic technique targeting the sensory distribution of the maxillary nerve and is particularly preferred to provide analgesia in midfacial and maxillary surgical procedures. It has been used to optimize perioperative and postoperative pain control, reduce intraoperative opioid requirements, and support hemodynamic stability in procedures including septorhinoplasty, nasal bone osteotomies, nasal valve surgery, and endoscopic sinus surgery. This study aimed to compare the effects of the timing of bilateral maxillary nerve block administration (post-intubation vs. pre-extubation) on intraoperative remifentanil consumption and postoperative analgesia in patients undergoing septorhinoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Maxillary Block | Active comparator | Drug: Preoperative Maxillary BlockAfter the intubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa. Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions. A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle. The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique. After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side. The same procedure will subsequently be repeated contralaterally. |
| Postoperative Maxillary Block | Active comparator | Drug: Postoperative Maxillary BlockAt the end of the surgery, before the extubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa. Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions. A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle. The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique. After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side. The same procedure will subsequently be repeated contralaterally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II
- Body mass index 18 to 30 kg/m2
- Septorhinoplasty surgery
Key exclusion criteria (6 listed)
- Patient refusing the procedure
- Patients who have previously undergone nasal surgery
- Chronic opioid or analgesic use
- Patients with allergies to local anesthetics
- Patients with Hypertension
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 |
|---|---|---|
| Preoperative Maxillary BlockAfter the intubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa. Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions. A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle. The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique. After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side. The same procedure will subsequently be repeated contralaterally. | Drug | Preoperative Maxillary Block |
| Postoperative Maxillary BlockAt the end of the surgery, before the extubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa. Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions. A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle. The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique. After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side. The same procedure will subsequently be repeated contralaterally. | Drug | Postoperative Maxillary Block |
Primary outcome
Intraoperative remifentanil consumption
Time frame: Intraoperative period
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.
3 secondary outcomes
Mean arterial pressure
Time frame: Intraoperative period
Heart rate
Time frame: Intraoperative period
Pain scores
Time frame: First 24 hours after 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 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Maxillary Block and Postoperative Maxillary Block in people with Septorhinoplasty and Remifentanil Consumption, run by Atatürk Chest Diseases and Chest Surgery 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 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 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?
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?
Contact Musa Zengin, Associate Professor (05307716235, musazengin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative remifentanil consumption (time frame: Intraoperative period). 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 2 Jun 2026.