Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty

Study Overview
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Brief Summary
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The purpose of this study is to determine whether bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty are effective in preventing emergence agitation.

Detailed Description
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Emergence agitation is a postanesthetic phenomenon characterized as confusion, disorientation and violent behavior. Although its etiology is not well understood, risk factors associated with the condition include pain and ENT (ear, nose and throat) surgery. Bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty is effective in treating postoperative pain. The investigators have designed this study to evaluate the effect of infraorbital and infratrochlear nerve block on emergence agitation in patients undergoing septorhinoplasty.

Official Title
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Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty: A Randomized Controlled Trial

Conditions
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Emergence Agitation, Pain

Intervention / Treatment
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* Drug: Normal Saline
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Septorhinoplasty American Society of Anesthesiologists (ASA) classification I-II Written informed consent Exclusion Criteria: ASA classification greater than III Allergy to ropivacaine Incapability to give consent Chronic pain Coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>placebo for the realization of infraorbital and infratrochlear block | Drug: Normal Saline<br>* Bilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline<br>|
| Active Comparator: Ropivacaine<br>ropivacaine for the realization of infraorbital and infratrochlear block | Drug: Ropivacaine<br>* Bilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence agitation | Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7 | 2 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | 0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable | 2, 8, 24, 48 hours after surgery | 
| Patient satisfaction | 1-5 scale (1: very unsatisfactory, 2: rather unsatisfactory, 3: fair, 4: rather satisfactory, 5: very satisfactory) | 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infraorbital nerve block, infratrochlear nerve block, septorhinoplasty, general anesthesia, postoperative analgesia