NCT07233538 Preoperative Maxillary Nerve Block and Remifentanil Use in Septorhinoplasty
| NCT ID | NCT07233538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara Etlik City Hospital |
| Condition | Head and Neck Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2026-11-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-08-20 with a primary completion date of 2026-11-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Emine ARIK, Associate Professor
STUDY DIRECTOR
Ankara Etlik City Hospital
Frequently Asked Questions
Who can join the NCT07233538 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Head and Neck Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07233538 currently recruiting?
Yes, NCT07233538 is actively recruiting participants. Contact the research team at drcanozan@gmail.com for enrollment information.
Where is the NCT07233538 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07233538 clinical trial?
NCT07233538 is sponsored by Ankara Etlik City Hospital. The principal investigator is Emine ARIK, Associate Professor at Ankara Etlik City Hospital. The trial plans to enroll 90 participants.