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NCT07233538: PRISM

Preoperative Maxillary Nerve Block and Remifentanil Use in Septorhinoplasty

Recruiting now NA Last updated 18 November 2025
What this trial tests

NA trial testing Maxillary block in Head and Neck Surgery in 90 participants. Currently enrolling.

Timeline
20 August 2025
Primary endpoint
8 November 2026
8 December 2026

Quick facts

Lead sponsorAnkara Etlik City Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment90
Start date20 August 2025
Primary completion8 November 2026
Estimated completion8 December 2026
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Ankara Etlik City Hospital

Who can join

Adults 18 to 65, any sex, with Head and Neck Surgery or Plastic Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Ankara Etlik City Hospital trials

Trials by the same sponsor.

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Data sources for this page

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