Preoperative Maxillary Nerve Block and Remifentanil Use in Septorhinoplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara Etlik City Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Maxillary block
Procedure/SurgeryBilateral maxillary nerve block in the preoperative phase
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Group MaxillaryActive comparator 1 intervention
Group B: Group controlNo intervention 0 interventions
Trial outcomes
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
Time frame
İntraoperative-From induction of anesthesia to extubation (anesthesia duration)Secondary outcomes
1
Intraoperative sevoflurane consumption
At extubation, the anesthesia machine's agent-consumption display will be checked and the total sevoflurane usage recorded. The amount of sevoflurane used for the patient will be documented in milliliters (mL)
Time frame
İntraoperative-İntraoperative-From induction of anesthesia to extubation (anesthesia duration)2
Extubation time
Following completion of the surgical procedure, administration of remifentanil and sevoflurane anesthesia will be discontinued. The time measurement will start at the moment of discontinuation. The patient will be observed until the return of spontaneous breathing, and the time interval between anesthesia discontinuation and tracheal extubation will be recorded in seconds (s).
Time frame
From the discontinuation of remifentanil and sevoflurane anesthesia until the time of tracheal extubation, assessed up to 30 minutes post-anesthesia discontinuation3
Postoperative pain
Postoperative pain will be assessed at hour 0 and subsequently at 1, 2, 4, 6, 12, and 24 hours using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain).
Time frame
Postoperative day 1 (0-24 hours)4
Anesthesiologist, surgeon and patient satisfaction will be evaluated
Immediately after surgery, surgeon and anesthesiologist satisfaction will be assessed. At 24 hours postoperatively, the patient will be asked to rate overall perioperative satisfaction. Surgeon, anesthesiologist, and patient satisfaction will be scored on a 5-point Likert scale: 1 = far below expectations; 2 = below expectations; 3 = met expectations; 4 = above expectations; 5 = far above expectations. For all items, the scale will be anchored such that 5 indicates the best score and 1 the worst.
Time frame
Satisfaction ratings for the surgeon and anesthesiologist will be obtained immediately after surgery; the patient will be assessed at 24 hours postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov