Efficacy of External Nasal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries

Study Overview
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Brief Summary
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Emergence agitation following general anaesthesia may lead to serious complications like self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia, bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence agitation. The investigators planned to evaluate the efficacy of external nasal nerve block in prevention of postoperative agitation following external nasal surgeries under general anesthesia(GA).

Official Title
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Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial

Conditions
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Agitation States as Acute Reaction to Gross Stress

Intervention / Treatment
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* Procedure: External nasal nerve block
* Drug: saline adrenaline
* Drug: Xylocaine, adrenaline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 110 adult patients of ASA physical status I and II, Age 20-60 years, Scheduled for elective external nasal surgeries in which nasal packing on each side was used postoperatively for 24 hours. Exclusion Criteria: History of uncontrolled hypertension, Ischemic or valvular heart disease, Use of MAO inhibitors or adrenergic blocking drugs, Cognitive impairment, Patients taking antipsychotics, Renal insufficiency or liver dysfunction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I(control)<br>patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo) | Procedure: External nasal nerve block<br>* Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.<br>Drug: saline adrenaline<br> <br> |
| Active Comparator: Group II(block)<br>'External nasal nerve block by Xylocaine, adrenaline' | Procedure: External nasal nerve block<br>* Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.<br>Drug: Xylocaine, adrenaline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative agitation | Assessment done using Richmond agitation- sedation scale (RASS) | Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation. | 
| Quality of recovery | Quality of recovery | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose of fentanyl | Fentanyl boluses were given in response to changes in hemodynamics (more than 15% increases in MAP and HR than the baseline values taken after induction by 5 minutes) | intraoperative period in minutes | 
| morphine dose in PACU | equivalent morphine dose in PACU (calculated using opioid:morphine equivalents of 100 µg i.v. fentanyl to 10 mg i.v. morphine; 75- 100 mg IV pethidine to 10 mg i.v. morphine | one hour in PACU | 
| Nausea and vomiting in PACU | Four-point nausea and vomiting scale (0=no nausea; 1=mild nausea; 2=severe nausea requiring antiemetics; and 3=retching, vomiting, or both) was also evaluated | one hour in PACU | 
| Extubation time |  | Up to 15 after discontinuation of anesthesia | 
| Surgical time | intraoperative | duration of surgery in minutes up to 3 hours | 
| first verbal response time | period from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes | up to 15 minutes | 
| complication of nasal block | including local anesthetic systemic toxicity, vascular injury, intravascular injection of local anesthetic, and local hematoma. | From injection to 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal surgery, external nasal nerve block, postoperative agitation