Preoperative Maxillary Nerve Block and Remifentanil Use in Septorhinoplasty

NCT07233538 | Recruiting

• 1 other identifier: AEŞH-EK-2025-191
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Surgery; Plastic Surgery; Rhinoplasty; Pain; Regional Anaesthesia; Nerve Blocks

Outcome Measures

Primary Outcomes (1)

• 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

  İntraoperative-From induction of anesthesia to extubation (anesthesia duration)

Secondary Outcomes (6)

• Intraoperative sevoflurane consumption

  İntraoperative-İntraoperative-From induction of anesthesia to extubation (anesthesia duration)

• Extubation time

  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 day 1 (0-24 hours)

• Anesthesiologist, surgeon and patient satisfaction will be evaluated

  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)

  İntraoperative ( during extubation)

Study Arms (2)

Group Maxillary

ACTIVE COMPARATOR

Maxillary block group And General Anesthesia

Procedure: Maxillary block

Group control

NO INTERVENTION

Only General Anesthesia

Interventions

Maxillary block PROCEDURE

Bilateral maxillary nerve block in the preoperative phase

Group Maxillary

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emine ARIK, Associate Professor

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Central Study Contacts

Can ozan Yazar, MD

CONTACT

+905065022395; drcanozan@gmail.com

Emine ARIK, Associate Professor

CONTACT

0905333471530; emineincearik@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: November 18, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): November 8, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TU (1)