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Clinical Trials in Turkey / NCT07233538
Recruiting Not applicable

Preoperative Maxillary Nerve Block and Remifentanil Use in Septorhinoplasty

NCT07233538 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-08-20
Last updated
2025-11-18

Condition(s) studied

Head and Neck SurgeryPlastic SurgeryRhinoplastyPainRegional AnaesthesiaNerve Blocks

Investigational drug(s) / intervention(s)

Maxillary block

Maxillary block: Bilateral maxillary nerve block in the preoperative phase

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ankara Etlik City Hospital Ankara Yenimahalle Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07233538 on ClinicalTrials.gov ↗ ← All trials in Turkey