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

NCT07345039 | Completed

• 1 other identifier: 12.2.2025-521
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Intensity

  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

  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 Outcomes (4)

• Total Tramadol Consumption

  First 24 hours postoperative

• Incidence of Postoperative Nausea and Vomiting (PONV)

  0-24 hours postoperative

• Adverse Events in PACU

  Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)

• Patient Satisfaction Score

  At 24 hours postoperative

Study Arms (2)

Infraorbital-Infratrochlear Nerve Block (ION-ITN Block)

ACTIVE COMPARATOR

Infraorbital-Infratrochlear Nerve Block (ION-ITN Block)

Procedure: Infraorbital-Infratrochlear Nerve Block

Sphenopalatine Ganglion Block

ACTIVE COMPARATOR

Transnasal Sphenopalatine Ganglion Block (SPG Block)

Procedure: Transnasal Sphenopalatine Ganglion Block

Interventions

Infraorbital-Infratrochlear Nerve Block PROCEDURE

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

Infraorbital-Infratrochlear Nerve Block (ION-ITN Block)

Transnasal Sphenopalatine Ganglion Block PROCEDURE

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

Sphenopalatine Ganglion Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Turkey, 21070, Turkey (Türkiye)

Location

Related Publications (1)

• Can E, Akkaya OT. A Comparison of Transnasal Versus Ultrasound-Guided Suprazygomatic Approaches for Sphenopalatine Ganglion Blocks in Persistent Idiopathic Facial Pain. Ann Indian Acad Neurol. 2025 Mar 1;28(2):189-195. doi: 10.4103/aian.aian_713_24. Epub 2025 Mar 13.

  PMID: 40087987 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, surgeons, anesthesiologists assessing postoperative outcomes, follow-up investigators, and data analysts were all blinded to group allocation throughout the perioperative period.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm, parallel-group, randomized and double-blind clinical trial comparing infraorbital-infratrochlear nerve block with transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 15, 2026
• Study Start: January 16, 2026
• Primary Completion: March 30, 2026
• Study Completion: March 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

TU (1)