Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

Study Overview
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Brief Summary
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Postoperative agitation is an important complication of general anesthesia, moreover, it has been found with high incidence in ear, nose, throat (ENT) surgeries. We aim to study whether anterior ethmoidal nerve block will be successful in reducing postoperative agitation in those patients. Study population will be randomized into two groups, treatment and control group. Anterior ethmoidal nerve block will be done in treatment group and postoperative agitation compared between these two groups. Agitation score will be scored with Riker Sedation-Agitation Scale (SAS). Ho: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is equal in those with ethmoidal nerve block as compared to those without the block. Ha: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is not equal in those with ethmoidal nerve block as compared to those without the block.

Official Title
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Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries With Nasal Packs Under General Anesthesia: A Double Blind Randomized Control Trial

Conditions
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Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia, Deviated Nasal Septum, Chronic Rhinosinusitis (Diagnosis), Nasal Polyps

Intervention / Treatment
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* Drug: Bupivacaine-epinephrine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing nasal surgery Under General Anesthesia With nasal packs Exclusion Criteria: Do not consent to the study. History of allergy to lignocaine or bupivacaine
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Experimental: Study Group At the end of surgery before nasal packing, scrub nurse will prepare 10 ml solution 0.5% bupivacaine with 1:2,00,000 adrenaline in a syringe and pass it over to the operating surgeon. The surgeon will block anterior ethmoidal nerve. Injection technique: External nasal nerve will be blocked through an inter-cartilaginous injection into the dorsum of the nose. Internal nasal nerve will be blocked in septum and lateral wall of nose. Septal block is done in upper anterior part of nasal septum. Three injections will be given on lateral nasal wall. First injection will be given just antero-superior to the attachment of middle turbinate (axilla). Second injection will be given at the anterior end of middle turbinate and third injection at the medial surface of middle turbinate. Withdrawal of injection will be done prior to deposition of solution every time to ensure that the solution is not deposited directly into a blood vessel. | Drug: Bupivacaine-epinephrine<br>* 10 ml of 0.5% bupivacaine with 1:2,00,000 adrenaline. For children less than 12 years of age, 0.25% bupivacaine with 1:2,00,000 adrenaline<br>|
| Placebo Comparator: Control Group<br>At the end of surgery before nasal packing, scrub nurse will pass 10 ml of normal saline in a syringe to the surgeron. Injection technique remains the same as in Study group. | Drug: normal saline<br>* normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative agitation | It will be assessed with Riker Sedation-Agitation Scale (SAS). It is a Likert scale with scores from 1 to 7 where 1 indicates unarousable (Minimal or no response to noxious stimuli, does not communicate or follow commands) and 7 indicates Dangerous agitation (Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side). A higher value indicates worse outcome. | After extubation before leaving operation table, an average of 10 minutes | 
| Postoperative agitation | It will be assessed with Riker Sedation-Agitation Scale (SAS). It is a Likert scale with scores from 1 to 7 where 1 indicates unarousable (Minimal or no response to noxious stimuli, does not communicate or follow commands) and 7 indicates Dangerous agitation (Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side). A higher value indicates worse outcome. | 30 minutes after first score. | 
| Postoperative agitation | It will be assessed with Riker Sedation-Agitation Scale (SAS) | 9:00 AM next morning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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general anesthesia, nasal surgery, anterior ehtmoidal nerve block, bupivacaine, postoperative confusion