Maxillary nerve block before septorhinoplasty to reduce opioid needs
Effect of Preoperative Ultrasound-guided Bilateral Maxillary Nerve Block Via the Pterygopalatine Fossa on Intraoperative Remifentanil Use in Septorhinoplasty
This trial will test whether giving a bilateral maxillary nerve block before general anesthesia reduces intraoperative remifentanil use and improves postoperative pain for adults having elective septorhinoplasty.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 1 site (Ankara, Yenimahalle) |
| Trial ID | NCT07233538 on ClinicalTrials.gov |
What this trial studies
Ninety patients undergoing elective septorhinoplasty will be assigned to two groups of 45: one group will receive bilateral maxillary nerve blocks plus general anesthesia and the other will receive general anesthesia alone. The study will measure intraoperative remifentanil consumption, hemodynamic stability during surgery, and postoperative pain scores and analgesic requirements. Patients meeting ASA I–II and BMI 18–30 criteria will be included and common contraindications to regional anesthesia will exclude participants. The approach aims to determine whether preoperative regional anesthesia can lower opioid needs and improve pain control after nasal bone and soft-tissue surgery.
Who should consider this trial
Good fit: Adults scheduled for elective septorhinoplasty who are ASA I–II, have a BMI between 18 and 30, and can cooperate with preoperative procedures are ideal candidates.
Not a fit: Patients with contraindications to regional anesthesia (for example coagulation disorders, infection at the injection site), ASA III or higher, prior surgery in the block area, chronic opioid use, or chronic pain are unlikely to be eligible or receive benefit.
Why it matters
Potential benefit: If successful, the intervention could reduce intraoperative opioid use and lower postoperative pain and opioid requirements after septorhinoplasty.
How similar studies have performed: Other regional anesthesia techniques for facial and nasal surgery have reduced opioid requirements and improved pain control in prior studies, though large randomized data specifically for preoperative maxillary nerve blocks in septorhinoplasty are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Ankara, Yenimahalle
- Ankara Etlik City Hospital — Ankara, Yenimahalle, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Can ozan Yazar, MD
- Email: drcanozan@gmail.com
- Phone: +905065022395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.