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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-16

Study Completion Date

2026-03-26

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Patients, surgeons, anesthesiologists assessing postoperative outcomes, follow-up investigators, and data analysts were all blinded to group allocation throughout the perioperative period.

Study Groups

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Infraorbital-Infratrochlear Nerve Block (ION-ITN Block)

Group Type ACTIVE_COMPARATOR

Infraorbital-Infratrochlear Nerve Block

Intervention Type PROCEDURE

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

Sphenopalatine Ganglion Block

Transnasal Sphenopalatine Ganglion Block (SPG Block)

Group Type ACTIVE_COMPARATOR

Transnasal Sphenopalatine Ganglion Block

Intervention Type PROCEDURE

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

Interventions

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Infraorbital-Infratrochlear Nerve Block

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

Intervention Type PROCEDURE

Transnasal Sphenopalatine Ganglion Block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No