Actively Recruiting
Effect of Preoperative Ultrasound-Guided Bilateral Maxillary Nerve Block Via the Pterygopalatine Fossa on Intraoperative Remifentanil Use in Septorhinoplasty
Led by Ankara Etlik City Hospital · Updated on 2025-11-18
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a bilateral maxillary nerve block on pain management and remifentanil use during septorhinoplasty, a nasal surgery that often involves bone cutting and can cause significant bleeding and pain. The study includes 90 patients undergoing elective septorhinoplasty, aiming to compare the amount of remifentanil used during surgery between those receiving the nerve block and those who do not. The goal is to improve pain control and maintain stable blood pressure throughout the operation. Before surgery, patients in one group will receive an ultrasound-guided bilateral maxillary nerve block via the pterygopalatine fossa, in addition to general anesthesia, while the other group will have general anesthesia only. Anesthesia includes drugs like fentanyl, propofol, and rocuronium for induction, with maintenance by sevoflurane and remifentanil infusion adjusted according to blood pressure. Multimodal pain relief with intravenous dexketoprofen and paracetamol will be given around the time of surgery completion. Various intraoperative factors like remifentanil and sevoflurane use, bleeding, surgery duration, and extubation time will be recorded. Participants will be closely monitored before, during, and after surgery. Pain will be assessed using a Numeric Rating Scale at multiple time points up to one month after surgery. The Quality of Recovery-15 questionnaire will be completed before surgery, 24 hours after, and at one month. Satisfaction levels of patients, anesthesiologists, and surgeons will also be measured. The study focuses on understanding whether the nerve block can reduce opioid use and improve postoperative recovery and comfort.
CONDITIONS
Brief Title
Preoperative Maxillary Nerve Block and Remifentanil Use in Septorhinoplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Body mass index (BMI) between 18 and 30
- Scheduled for elective septorhinoplasty surgery
- Fully cooperative patients
You will not qualify if you...
- Conditions contraindicating regional anesthesia (e.g., coagulation disorders, thrombocytopenia, severe valvular heart disease, local infection at injection site, allergy to local anesthetics)
- International Normalized Ratio (INR) greater than 1.5
- Facial paralysis or history of facial paralysis
- History of central nervous system vascular disease
- Presence of neuropathy
- Previous surgery in the area planned for nerve block
- ASA physical status III or higher
- Unwillingness to participate
- Chronic pain or chronic opioid use
- Alcohol, substance, or drug addiction
- Limited cooperation due to dementia or psychiatric disorders
- Pregnant or breastfeeding
- Inability to communicate in native language or language of the study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Same day as surgery
Participants undergo preoperative assessments including vital signs and a Quality of Recovery-15 questionnaire. Those assigned to the nerve block group receive a bilateral maxillary nerve block and monitoring before surgery.
1 screening and enrollment visit
Duration - Duration of surgery and anesthesia
Participants undergo septorhinoplasty surgery under general anesthesia. Intraoperative analgesia is managed with or without a bilateral maxillary nerve block, and vital signs are closely monitored throughout.
1 intraoperative procedure visit
Duration - 24 hours post-surgery
Participants are monitored for pain and recovery in the first 24 hours after surgery. Pain assessments are conducted at multiple time points, and a Quality of Recovery-15 questionnaire is completed at 24 hours.
Multiple visits at 0, 1, 2, 4, 6, 12, and 24 hours
Duration - 1 month post-surgery
Participants complete a final Quality of Recovery-15 questionnaire one month after surgery to assess recovery.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Ankara Etlik City Hospital
Ankara, Yenimahalle, Turkey (Türkiye)
Actively Recruiting
Research Team
C
Can ozan Yazar, MD
E
Emine ARIK, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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