Last reviewed · How we verify
NCT07233538: PRISM
Preoperative Maxillary Nerve Block and Remifentanil Use in Septorhinoplasty
NA trial testing Maxillary block in Head and Neck Surgery in 90 participants. Currently enrolling.
8 November 2026
Quick facts
| Lead sponsor | Ankara Etlik City Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 90 |
| Start date | 20 August 2025 |
| Primary completion | 8 November 2026 |
| Estimated completion | 8 December 2026 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Maxillary block
Conditions studied
- Head and Neck Surgery — all drugs for Head and Neck Surgery →
- Plastic Surgery — all drugs for Plastic Surgery →
- Rhinoplasty — all drugs for Rhinoplasty →
- Pain — all drugs for Pain →
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.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07233538 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ankara Etlik City Hospital
- Last refreshed: 18 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07233538.
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