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

March 31, 2026 updated by: Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Turkey
      • Diyarbakır, Turkey, Turkey (Türkiye), 21070
        • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Infraorbital-Infratrochlear Nerve Block (ION-ITN Block)
Procedure: Infraorbital-Infratrochlear Nerve Block
Bilateral infraorbital and infratrochlear nerve block performed with 0.5% bupivacaine after induction of general anesthesia
Active Comparator: Sphenopalatine Ganglion Block
Transnasal Sphenopalatine Ganglion Block (SPG Block)
Procedure: Transnasal Sphenopalatine Ganglion Block
Transnasal sphenopalatine ganglion block performed after induction of general anesthesia using local anesthetic-soaked applicators

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-24 hours postoperative
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.
Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Tramadol Consumption
Time Frame: First 24 hours postoperative
Total amount of intravenous tramadol administered as postoperative analgesia.
First 24 hours postoperative
Incidence of Postoperative Nausea and Vomiting (PONV)
Time Frame: 0-24 hours postoperative
Occurrence of nausea or vomiting requiring treatment with ondansetron.
0-24 hours postoperative
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.
Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)
Patient Satisfaction Score
Time Frame: At 24 hours postoperative
Patient satisfaction assessed using a 5-point Likert scale (1 = very unsatisfied, 5 = very satisfied).
At 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2026

Primary Completion (Actual)

March 30, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 12.2.2025-521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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