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

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status: Enrolling

Conditions: Postoperative Analgesia

Treatments: Procedure: Infraorbital-Infratrochlear Nerve Block; Procedure: Transnasal Sphenopalatine Ganglion Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07345039

12.2.2025-521

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups

Infraorbital-Infratrochlear Nerve Block (ION-ITN Block)

Active Comparator group

Description:

Infraorbital-Infratrochlear Nerve Block (ION-ITN Block)

Treatment:

Procedure: Infraorbital-Infratrochlear Nerve Block

Sphenopalatine Ganglion Block

Active Comparator group

Description:

Transnasal Sphenopalatine Ganglion Block (SPG Block)

Treatment:

Procedure: Transnasal Sphenopalatine Ganglion Block