Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, Turkey, 21070, Turkey (Türkiye)
NCT Number: NCT07345039
This prospective, randomized, double-blind clinical trial aims to compare the postoperative analgesic efficacy and recovery outcomes of infraorbital-infratrochlear nerve block and transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty under general anesthesia. Adult patients aged 18-65 years with ASA I-II status will be randomized to receive either bilateral infraorbital-infratrochlear block or transnasal sphenopalatine ganglion block after induction of anesthesia. Postoperative outcomes including pain scores (NRS at 0-2 h, 2-8 h, and 8-24 h), emergence agitation, Riker Sedation-Agitation Scale (RSAS) scores, time to first rescue analgesic, total tramadol consumption, adverse events, surgical site complications, and patient satisfaction will be assessed and compared between groups.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Diyarbakır, Turkey, 21070, Turkey (Türkiye)
This study is designed to evaluate the postoperative analgesic efficacy and clinical outcomes of two regional anesthesia techniques-infraorbital-infratrochlear nerve block (ION-ITN block) and transnasal sphenopalatine ganglion block (usg guided sphenopalatine ganglion block,SPG block)-in patients undergoing septorhinoplasty under general anesthesia. Eligible patients aged 18-65 years with ASA physical status I-II will be randomly assigned to one of two intervention groups. Blocks will be performed after induction by an anesthesiologist not involved in postoperative assessment. Patients, surgeons, anesthesiologists performing postoperative evaluations, follow-up investigators, and data analysts will remain blinded to group allocation.
Postoperative outcomes will include pain intensity assessed using the Numerical Rating Scale (NRS) at 0-2, 2-8, and 8-24 hours after surgery, agitation between extubation and PACU discharge assessed with the Riker Sedation-Agitation Scale (RSAS), emergence agitation (RSAS ≥5), time to first rescue analgesic, and total tramadol consumption within 24 hours. Additional outcomes include postoperative nausea and vomiting, cardiovascular and respiratory adverse events, surgical site complications (edema, hematoma, neurologic deficit), and patient satisfaction measured by a 5-point Likert scale. Preoperative demographics, BMI, ASA class, comorbidities, anesthesia and surgery duration, and intraoperative remifentanil consumption will be recorded. The study aims to determine whether SPG block provides superior postoperative analgesia compared with ION-ITN block in septorhinoplasty patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bilateral infraorbital and infratrochlear nerve block performed with 0.5% bupivacaine after induction of general anesthesia
Transnasal sphenopalatine ganglion block performed after induction of general anesthesia using local anesthetic-soaked applicators
Time frame: 0-24 hours postoperative
Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10) at three postoperative intervals: 0-2 hours, 2-8 hours, and 8-24 hours. Higher scores indicate greater pain.
Time frame: Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)
Agitation severity assessed using the Riker Sedation-Agitation Scale (RSAS). The highest postoperative RSAS score is recorded. RSAS ≥5 is defined as emergence agitation.
Time frame: First 24 hours postoperative
Total amount of intravenous tramadol administered as postoperative analgesia.
Time frame: 0-24 hours postoperative
Occurrence of nausea or vomiting requiring treatment with ondansetron.
Time frame: Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)
Respiratory or cardiovascular events including oxygen desaturation, airway obstruction, hypotension, hypertension, or arrhythmia.
Time frame: At 24 hours postoperative
Patient satisfaction assessed using a 5-point Likert scale (1 = very unsatisfied, 5 = very satisfied).
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Other
Comparison of Infraorbital-Infratrochlear Nerve Block and Transnasal Sphenopalatine Ganglion Block on Postoperative Analgesia and Recovery Outcomes in Septorhinoplasty: A Prospective, Randomized, Double-Blind Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06894420
Bites and Stings, Chemically-Induced Disorders
Başakşehir, Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06837532
Local Anesthesia Infiltration, Postoperative Analgesia
Cairo, Egypt
View Trial DetailsNCT06681493
Postoperative Analgesia
Changsha, China
View Trial DetailsNCT06949852
Postoperative Analgesia
Beijing, China
View Trial Details