Head and Neck SurgeryPRISMNCT07233538
Preoperative Maxillary Nerve Block and Remifentanil Use in Septorhinoplasty
A study testing Maxillary block in people with Head and Neck Surgery and Plastic Surgery, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Septorhinoplasty is generally a prolonged surgical procedure that frequently involves osteotomy, which may lead to increased intraoperative remifentanil requirements. Moreover, it is often associated with significant bleeding due to the dense capillary network of the nasal region, making the maintenance of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Head and Neck Surgery, Plastic Surgery, Rhinoplasty
- What is being tested?
- Maxillary block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2025to 8 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
- Those with an ASA (American Society of Anesthesiologists) score of I-II
- Those with a body mass index (BMI) between 18 and 30
- Those scheduled for elective surgery
- Those who are fully cooperative Patients who meet the criteria for septorhinoplasty surgery
Who cannot join
- Conditions that constitute a relative contraindication to regional anesthesia (e.g., coagulation disorders, thrombocytopenia, severe valvular heart disease, local infection at the injection site, allergy to local anesthetic agents)
- International Normalized Ratio (INR) > 1.5
- Facial paralysis or a history of facial paralysis
- History of central nervous system vascular disease
- Presence of neuropathy
- History of surgery in the region where the block will be performed
Show all 13Show fewer
- American Society of Anesthesiologists (ASA) physical status classification of III or higher
- Patients who do not want to participate in the study
- Patients with chronic pain or chronic opioid use
- Patients with alcohol, substance or drug addiction
- Patients with limited cooperation such as dementia, psychiatric disorders
- Pregnant and breastfeeding patients will be excluded from the study.
- Patients who cannot communicate in their native language will be excluded from the study
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
Ankara, Yenimahalle
Ankara Etlik City Hospital Ankara Etlik City Hospital, +903127970000, etliksh.etikkurul@saglik.gov.tr
Can Ozan Yazar, MD
About this study
Official title: Effect of Preoperative Ultrasound-guided Bilateral Maxillary Nerve Block Via the Pterygopalatine Fossa on Intraoperative Remifentanil Use in Septorhinoplasty
Septorhinoplasty is generally a prolonged surgical procedure that frequently involves osteotomy, which may lead to increased intraoperative remifentanil requirements. Moreover, it is often associated with significant bleeding due to the dense capillary network of the nasal region, making the maintenance of low-to-normal blood pressure preferable during surgery. Consequently, achieving stable hemodynamics and providing sufficient analgesia throughout the procedure is essential.
This study aims to evaluate the effects of bilateral maxillary nerve block on intraoperative remifentanil consumption and postoperative analgesic efficacy in patients undergoing Septorhinoplasty. A total of 90 patients will be included in the study. Forty-five patients (Group M) will undergo Septorhinoplasty under general anesthesia combined with bilateral maxillary nerve block, while the remaining 45 patients (Group N) will receive general anesthesia alone.
Read more
In the preoperative phase, a bilateral maxillary nerve block will be performed under ultrasound guidance via the pterygopalatine fossa. During the intraoperative period, total remifentanil consumption will be recorded, alongside assessments of hemodynamic stability, sevoflurane consumption, extubation time, intraoperative bleeding volume, and the satisfaction levels of both the anesthesiologist and the surgeon.
In the postoperative period, patient satisfaction, pain scores at 0, 1, 2, 4, 6, 12, 18, and 24 hours as well as at 1 month (measured using the Visual Analog Scale - VAS), additional analgesic requirements, and Quality of Recovery-15 (QoR-15) scores (assessed on preoperative day 1, postoperative day 1, and at 1 month) will be evaluated.
Read the detailed description
Septorhinoplasty is a surgical procedure that involves reshaping the nasal soft tissues, cartilage, and bone, and it frequently requires osteotomy. Manipulation of these structures typically results in moderate to severe postoperative pain. Nearly 30% of patients report pain scores of 6 or higher on the Numeric Rating Scale (NRS). Additionally, the use of nasal tampons in the postoperative period may exacerbate discomfort.
For postoperative pain management, nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids may be used. The American Society of Anesthesiologists (ASA) recommends the use of multimodal analgesia combined with regional anesthesia techniques during the perioperative period for the management of acute pain. The incorporation of regional techniques enhances analgesic efficacy synergistically and helps reduce opioid requirements, thereby lowering the incidence of related adverse effects. Moreover, regional techniques applied in the preoperative period are known to support more stable hemodynamic responses.
The trigeminal nerve provides the primary sensory innervation of the face. Its maxillary branch (V2) innervates the nasopharynx, palate, nasal cavity, maxillary sinus, skin of the nasal sidewall, and upper lip. After exiting the middle cranial fossa, it passes through the foramen rotundum and enters the pterygopalatine fossa, where it gives rise to several sensory branches. Among these, the infraorbital and nasopalatine nerves supply sensory innervation to the nasal septum mucosa. The posterior, superior, and inferior lateral nasal nerves, which also arise from the maxillary nerve, innervate the superior, middle, and inferior turbinates. Other branches supply sensation to the skin of the nasal ala and upper lip.
Although bilateral isolated infraorbital nerve block-a branch of the maxillary nerve-has been shown to provide analgesia following nasal surgeries, several studies have reported that analgesia may remain insufficient even with the addition of an infratrochlear nerve block. Therefore, rather than targeting individual branches, blockade of the maxillary nerve itself has been proposed. For this purpose, ultrasound-guided injection via the pterygopalatine fossa has been described.
The aim of this study is to compare intraoperative remifentanil consumption between patients who receive a preoperative bilateral maxillary nerve block and those who do not.
The investigators hypothesize that bilateral maxillary nerve block provides effective intraoperative analgesia, reduces remifentanil requirements, and ensures adequate postoperative pain control.
A total of 90 patients will be enrolled. Randomization will be conducted using the closed-envelope method. The anesthesiologist performing the block and the anesthesiologist responsible for intraoperative and postoperative management will be different individuals, with the latter blinded to group allocation. Patients who receive the block will be assigned to Group M, while those who do not will be assigned to Group N. Group allocation will remain concealed from all personnel except the anesthesiologist administering the block and the study investigators.
All patients will undergo surgery under general anesthesia. A preoperative fasting period of 8 hours for both solids and liquids will be required. Upon admission to the preoperative observation clinic, noninvasive blood pressure (NIBP) and heart rate (HR) will be measured. The average preoperative NIBP and HR values will be calculated based on the last two recordings obtained in the ward. The Quality of Recovery-15 (QoR-15) questionnaire will also be administered at this time.
In the designated block area of the preoperative care unit, patients in Group M will receive a bilateral maxillary nerve block with 4 mL of 0.5% bupivacaine on each side (total volume: 8 mL). Following administration, patients will be monitored for 30 minutes. Successful blockade will be confirmed via a pinprick test prior to transfer to the operating room.
General anesthesia will be induced using intravenous fentanyl (0.5 mcg/kg), propofol (2.5 mg/kg), and rocuronium (0.6 mg/kg). Oral endotracheal intubation will then be performed. Anesthesia will be maintained with sevoflurane (1 MAC) and a continuous remifentanil infusion at a rate of 0.05-0.2 mcg/kg/min. NIBP, HR, and peripheral oxygen saturation will be monitored at 0, 5, 10, and 15 minutes, and every 15 minutes thereafter.
The remifentanil infusion rate will be adjusted based on intraoperative changes in mean arterial pressure (MAP) relative to the preoperative baseline:
- For MAP changes of 10-20%, the dose will be adjusted by ±25%.
- For changes of 20-30%, by ±50%.
- For changes exceeding 30%, by ±50-100%. The goal is to maintain MAP above 60 mmHg and within ±30% of the baseline value.
Thirty minutes prior to extubation, multimodal analgesia will be initiated with 50 mg of intravenous dexketoprofen and 1 g of intravenous paracetamol. During emergence, neuromuscular blockade will be reversed using intravenous neostigmine (0.02 mg/kg) and atropine (0.5 mg). Remifentanil and sevoflurane will be discontinued after surgical dressing, and extubation time will be recorded as the interval between anesthetic discontinuation and endotracheal tube removal.
Intraoperative bleeding will be assessed using the Boezaart Bleeding Score during airway suctioning before extubation (0 = no bleeding, 1 = mild bleeding not requiring suctioning, 2 = mild bleeding requiring occasional suctioning, 3 = mild bleeding requiring frequent suctioning, 4 = moderate bleeding, 5 = severe bleeding).
Total intraoperative remifentanil and sevoflurane consumption, duration of surgery, and total anesthesia time will be recorded. After surgery, patients will be transferred to the post-anesthesia care unit (PACU).
Postoperative pain will be assessed at hour 0 and subsequently at 1, 2, 4, 6, 12, and 24 hours using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). In accordance with the standard protocol of the otorhinolaryngology department, all patients will receive 50 mg of intravenous dexketoprofen twice daily during the postoperative period. For those requiring additional analgesia (NRS > 4), 1 g of intravenous paracetamol will be administered as rescue medication.
The Quality of Recovery-15 (QoR-15) questionnaire will be re-administered at 24 hours postoperatively and again at 1 month.
- Conditions
- Head and Neck Surgery, Plastic Surgery, Rhinoplasty, Pain, Regional Anaesthesia, Nerve Blocks
- Being tested
- Maxillary block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary blockProcedure or surgery
Bilateral maxillary nerve block in the preoperative phase
| Study group | Role | What they receive |
|---|---|---|
| Group Maxillary | Active comparator | Maxillary block group And General Anesthesia Receives: Procedure: Maxillary block |
| Group control | No intervention | Only General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption
Intraoperative remifentanil infusion will be initiated at 0.05 µg·kg-¹·min-¹. In accordance with the protocol, the rate will be titrated upward or downward based on arterial blood pressure, and the total intraoperative remifentanil dose will be recorded. The average remifentanil dose will be calculated by dividing the total dose by the total anesthesia time and the patient's body weight, and reported as µg·kg-¹·min-¹ and µg·kg-¹·h-¹
Measured: İntraoperative-From induction of anesthesia to extubation (anesthesia duration)
Secondary outcomes (6)
Intraoperative sevoflurane consumption
At extubation, the anesthesia machine's agent-consumption display will be checked and the total sevoflurane usage recorded. The amount of sevoflurane used for the patient will be documented in milliliters (mL)
Measured: İntraoperative-İntraoperative-From induction of anesthesia to extubation (anesthesia duration)
Extubation time
Following completion of the surgical procedure, administration of remifentanil and sevoflurane anesthesia will be discontinued. The time measurement will start at the moment of discontinuation. The patient will be observed until the return of spontaneous breathing, and the time interval between anesthesia discontinuation and tracheal extubation will be recorded in seconds (s).
Measured: From the discontinuation of remifentanil and sevoflurane anesthesia until the time of tracheal extubation, assessed up to 30 minutes post-anesthesia discontinuation
Postoperative pain
Postoperative pain will be assessed at hour 0 and subsequently at 1, 2, 4, 6, 12, and 24 hours using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain).
Measured: Postoperative day 1 (0-24 hours)
Anesthesiologist, surgeon and patient satisfaction will be evaluated
Immediately after surgery, surgeon and anesthesiologist satisfaction will be assessed. At 24 hours postoperatively, the patient will be asked to rate overall perioperative satisfaction. Surgeon, anesthesiologist, and patient satisfaction will be scored on a 5-point Likert scale: 1 = far below expectations; 2 = below expectations; 3 = met expectations; 4 = above expectations; 5 = far above expectations. For all items, the scale will be anchored such that 5 indicates the best score and 1 the worst.
Measured: Satisfaction ratings for the surgeon and anesthesiologist will be obtained immediately after surgery; the patient will be assessed at 24 hours postoperatively.
Postoperative bleeding index (Boezaart Bleeding Score)
Boezaart Bleeding Score during airway suctioning before extubation (0 = no bleeding, 1 = mild bleeding not requiring suctioning, 2 = mild bleeding requiring occasional suctioning, 3 = mild bleeding requiring frequent suctioning, 4 = moderate bleeding, 5 = severe bleeding)
Measured: İntraoperative ( during extubation)
The Quality of Recovery-15 (QoR-15) questionnaire
Administration and assessment time points This is a patient-reported outcome measure (PROM). In this study, it will be administered at three time points: (1) preoperative baseline; (2) 24 hours postoperatively; and (3) 1 month postoperatively. Instrument structure and scoring: The instrument comprises 15 items, each rated on a 0-10 numeric scale. Section A (10 items): 0 = never (poor), 10 = always (excellent). Higher scores indicate better well-being. Section B (5 symptom items): 0 = constantly (poor), 10 = never (excellent). The absence of symptoms is reflected by higher scores; therefore, no reverse-coding is required.Total score and interpretation. The total QoR-15 score is obtained by summing all 15 items and ranges from 0 to 150. Lowest possible total score (worst): 0,Highest possible total score (best): 150.
Measured: To be examined in the preoperative phase, at the 24th hour postoperatively and at the 1st month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start20 Aug 2025
- Primary completion8 Nov 2026 (estimated)
- Study completion8 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Can Ozan Yazar, Ankara Etlik City Hospital
- Investigators
- Emine ARIK, Associate Professor, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233538
- Sponsor's protocol ID
- AEŞH-EK-2025-191
- Acronym
- PRISM
- Status last verified
- Nov 2025
- First submitted
- 6 Aug 2025
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Ultrasound-guided Bilateral Maxillary Nerve Block Via the Pterygopalatine Fossa on Intraoperative Remifentanil Use in Septorhinoplasty
- ClinicalTrials.gov ID
- NCT07233538
- Acronym / sponsor ID
- PRISM / AEŞH-EK-2025-191
- Conditions
- Head and Neck Surgery, Plastic Surgery, Rhinoplasty, Pain, Regional Anaesthesia, Nerve Blocks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 8 Nov 2026 (estimated)
- Study completion
- 8 Dec 2026 (estimated)
- First posted
- 18 Nov 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.
Septorhinoplasty is generally a prolonged surgical procedure that frequently involves osteotomy, which may lead to increased intraoperative remifentanil requirements. Moreover, it is often associated with significant bleeding due to the dense capillary network of the nasal region, making the maintenance of low-to-normal blood pressure preferable during surgery. Consequently, achieving stable hemodynamics and providing sufficient analgesia throughout the procedure is essential.
This study aims to evaluate the effects of bilateral maxillary nerve block on intraoperative remifentanil consumption and postoperative analgesic efficacy in patients undergoing Septorhinoplasty. A total of 90 patients will be included in the study. Forty-five patients (Group M) will undergo Septorhinoplasty under general anesthesia combined with bilateral maxillary nerve block, while the remaining 45 patients (Group N) will receive general anesthesia alone.
In the preoperative phase, a bilateral maxillary nerve block will be performed under ultrasound guidance via the pterygopalatine fossa. During the intraoperative period, total remifentanil consumption will be recorded, alongside assessments of hemodynamic stability, sevoflurane consumption, extubation time, intraoperative bleeding volume, and the satisfaction levels of both the anesthesiologist and the surgeon.
In the postoperative period, patient satisfaction, pain scores at 0, 1, 2, 4, 6, 12, 18, and 24 hours as well as at 1 month (measured using the Visual Analog Scale - VAS), additional analgesic requirements, and Quality of Recovery-15 (QoR-15) scores (assessed on preoperative day 1, postoperative day 1, and at 1 month) will be evaluated.
Detailed description
Septorhinoplasty is a surgical procedure that involves reshaping the nasal soft tissues, cartilage, and bone, and it frequently requires osteotomy. Manipulation of these structures typically results in moderate to severe postoperative pain. Nearly 30% of patients report pain scores of 6 or higher on the Numeric Rating Scale (NRS). Additionally, the use of nasal tampons in the postoperative period may exacerbate discomfort.
For postoperative pain management, nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids may be used. The American Society of Anesthesiologists (ASA) recommends the use of multimodal analgesia combined with regional anesthesia techniques during the perioperative period for the management of acute pain. The incorporation of regional techniques enhances analgesic efficacy synergistically and helps reduce opioid requirements, thereby lowering the incidence of related adverse effects. Moreover, regional techniques applied in the preoperative period are known to support more stable hemodynamic responses.
The trigeminal nerve provides the primary sensory innervation of the face. Its maxillary branch (V2) innervates the nasopharynx, palate, nasal cavity, maxillary sinus, skin of the nasal sidewall, and upper lip. After exiting the middle cranial fossa, it passes through the foramen rotundum and enters the pterygopalatine fossa, where it gives rise to several sensory branches. Among these, the infraorbital and nasopalatine nerves supply sensory innervation to the nasal septum mucosa. The posterior, superior, and inferior lateral nasal nerves, which also arise from the maxillary nerve, innervate the superior, middle, and inferior turbinates. Other branches supply sensation to the skin of the nasal ala and upper lip.
Although bilateral isolated infraorbital nerve block-a branch of the maxillary nerve-has been shown to provide analgesia following nasal surgeries, several studies have reported that analgesia may remain insufficient even with the addition of an infratrochlear nerve block. Therefore, rather than targeting individual branches, blockade of the maxillary nerve itself has been proposed. For this purpose, ultrasound-guided injection via the pterygopalatine fossa has been described.
The aim of this study is to compare intraoperative remifentanil consumption between patients who receive a preoperative bilateral maxillary nerve block and those who do not.
The investigators hypothesize that bilateral maxillary nerve block provides effective intraoperative analgesia, reduces remifentanil requirements, and ensures adequate postoperative pain control.
A total of 90 patients will be enrolled. Randomization will be conducted using the closed-envelope method. The anesthesiologist performing the block and the anesthesiologist responsible for intraoperative and postoperative management will be different individuals, with the latter blinded to group allocation. Patients who receive the block will be assigned to Group M, while those who do not will be assigned to Group N. Group allocation will remain concealed from all personnel except the anesthesiologist administering the block and the study investigators.
All patients will undergo surgery under general anesthesia. A preoperative fasting period of 8 hours for both solids and liquids will be required. Upon admission to the preoperative observation clinic, noninvasive blood pressure (NIBP) and heart rate (HR) will be measured. The average preoperative NIBP and HR values will be calculated based on the last two recordings obtained in the ward. The Quality of Recovery-15 (QoR-15) questionnaire will also be administered at this time.
In the designated block area of the preoperative care unit, patients in Group M will receive a bilateral maxillary nerve block with 4 mL of 0.5% bupivacaine on each side (total volume: 8 mL). Following administration, patients will be monitored for 30 minutes. Successful blockade will be confirmed via a pinprick test prior to transfer to the operating room.
General anesthesia will be induced using intravenous fentanyl (0.5 mcg/kg), propofol (2.5 mg/kg), and rocuronium (0.6 mg/kg). Oral endotracheal intubation will then be performed. Anesthesia will be maintained with sevoflurane (1 MAC) and a continuous remifentanil infusion at a rate of 0.05-0.2 mcg/kg/min. NIBP, HR, and peripheral oxygen saturation will be monitored at 0, 5, 10, and 15 minutes, and every 15 minutes thereafter.
The remifentanil infusion rate will be adjusted based on intraoperative changes in mean arterial pressure (MAP) relative to the preoperative baseline:
- For MAP changes of 10-20%, the dose will be adjusted by ±25%.
- For changes of 20-30%, by ±50%.
- For changes exceeding 30%, by ±50-100%. The goal is to maintain MAP above 60 mmHg and within ±30% of the baseline value.
Thirty minutes prior to extubation, multimodal analgesia will be initiated with 50 mg of intravenous dexketoprofen and 1 g of intravenous paracetamol. During emergence, neuromuscular blockade will be reversed using intravenous neostigmine (0.02 mg/kg) and atropine (0.5 mg). Remifentanil and sevoflurane will be discontinued after surgical dressing, and extubation time will be recorded as the interval between anesthetic discontinuation and endotracheal tube removal.
Intraoperative bleeding will be assessed using the Boezaart Bleeding Score during airway suctioning before extubation (0 = no bleeding, 1 = mild bleeding not requiring suctioning, 2 = mild bleeding requiring occasional suctioning, 3 = mild bleeding requiring frequent suctioning, 4 = moderate bleeding, 5 = severe bleeding).
Total intraoperative remifentanil and sevoflurane consumption, duration of surgery, and total anesthesia time will be recorded. After surgery, patients will be transferred to the post-anesthesia care unit (PACU).
Postoperative pain will be assessed at hour 0 and subsequently at 1, 2, 4, 6, 12, and 24 hours using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). In accordance with the standard protocol of the otorhinolaryngology department, all patients will receive 50 mg of intravenous dexketoprofen twice daily during the postoperative period. For those requiring additional analgesia (NRS > 4), 1 g of intravenous paracetamol will be administered as rescue medication.
The Quality of Recovery-15 (QoR-15) questionnaire will be re-administered at 24 hours postoperatively and again at 1 month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Maxillary | Active comparator | Procedure: Maxillary blockMaxillary block group And General Anesthesia |
| Group control | No intervention | –Only General Anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those with an ASA (American Society of Anesthesiologists) score of I-II
- Those with a body mass index (BMI) between 18 and 30
- Those scheduled for elective surgery
- Those who are fully cooperative Patients who meet the criteria for septorhinoplasty surgery
Key exclusion criteria (13 listed)
- Conditions that constitute a relative contraindication to regional anesthesia (e.g., coagulation disorders, thrombocytopenia, severe valvular heart disease, local infection at the injection site, allergy to local anesthetic agents)
- International Normalized Ratio (INR) > 1.5
- Facial paralysis or a history of facial paralysis
- History of central nervous system vascular disease
- Presence of neuropathy
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 |
|---|---|---|
| Maxillary blockBilateral maxillary nerve block in the preoperative phase | Procedure or surgery | Group Maxillary |
Primary outcome
Intraoperative remifentanil consumption
Time frame: İntraoperative-From induction of anesthesia to extubation (anesthesia duration)
Intraoperative remifentanil infusion will be initiated at 0.05 µg·kg-¹·min-¹. In accordance with the protocol, the rate will be titrated upward or downward based on arterial blood pressure, and the total intraoperative remifentanil dose will be recorded. The average remifentanil dose will be calculated by dividing the total dose by the total anesthesia time and the patient's body weight, and reported as µg·kg-¹·min-¹ and µg·kg-¹·h-¹
6 secondary outcomes
Intraoperative sevoflurane consumption
Time frame: İntraoperative-İntraoperative-From induction of anesthesia to extubation (anesthesia duration)
Extubation time
Time frame: From the discontinuation of remifentanil and sevoflurane anesthesia until the time of tracheal extubation, assessed up to 30 minutes post-anesthesia discontinuation
Postoperative pain
Time frame: Postoperative day 1 (0-24 hours)
Anesthesiologist, surgeon and patient satisfaction will be evaluated
Time frame: Satisfaction ratings for the surgeon and anesthesiologist will be obtained immediately after surgery; the patient will be assessed at 24 hours postoperatively.
Postoperative bleeding index (Boezaart Bleeding Score)
Time frame: İntraoperative ( during extubation)
The Quality of Recovery-15 (QoR-15) questionnaire
Time frame: To be examined in the preoperative phase, at the 24th hour postoperatively and at the 1st month postoperatively
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 18 Nov 2025.
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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.
Emine ARIK, Associate Professor study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary block in people with Head and Neck Surgery and Plastic Surgery, run by Ankara Etlik 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 13 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 18 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 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 Can ozan Yazar, MD (+905065022395, drcanozan@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: İntraoperative-From induction of anesthesia to extubation (anesthesia duration)). 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 18 Nov 2025.