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Completed

NCT Number: NCT07345039

Infraorbital-Infratrochlear Block vs Sphenopalatine Ganglion Block for Postoperative Analgesia in Septorhinoplasty.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Turkey, 21070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-65 years.
  • Scheduled for septorhinoplasty under general anesthesia.
  • American Society of Anesthesiologists (ASA) Physical Status I-II.
  • Ability to cooperate with postoperative evaluations.
  • Provision of written informed consent.

Exclusion criteria

  • Allergy or contraindication to local anesthetics used in the study.
  • Coagulopathy or anticoagulant therapy.
  • Local infection at the nerve block application sites.
  • Severe nasal anatomical abnormalities preventing transnasal block application.
  • Psychiatric disorders affecting pain or agitation assessment..
  • Chronic pain conditions or chronic opioid use.
  • Neurological disorders affecting sensory perception.
  • Refusal to participate.

Treatment and study plan

Infraorbital-Infratrochlear Nerve Block

Procedure

Bilateral infraorbital and infratrochlear nerve block performed with 0.5% bupivacaine after induction of general anesthesia

Transnasal Sphenopalatine Ganglion Block

Procedure

Transnasal sphenopalatine ganglion block performed after induction of general anesthesia using local anesthetic-soaked applicators

Primary outcomes

  1. Postoperative Pain Intensity

    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.

  2. Postoperative Agitation

    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.

Secondary outcomes

  1. Total Tramadol Consumption

    Time frame: First 24 hours postoperative

    Total amount of intravenous tramadol administered as postoperative analgesia.

  2. Incidence of Postoperative Nausea and Vomiting (PONV)

    Time frame: 0-24 hours postoperative

    Occurrence of nausea or vomiting requiring treatment with ondansetron.

  3. Adverse Events in PACU

    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.

  4. Patient Satisfaction Score

    Time frame: At 24 hours postoperative

    Patient satisfaction assessed using a 5-point Likert scale (1 = very unsatisfied, 5 = very satisfied).

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Apr 1, 2026

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.

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