Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

Not Applicable

Completed

• Conditions: Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia; Chronic Rhinosinusitis (Diagnosis); Deviated Nasal Septum; Nasal Polyps
• Interventions: Drug: normal saline; Drug: Bupivacaine-epinephrine

• Registration Number: NCT03427502
• Lead Sponsor: Lumbini Medical College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-09
• Study Start: 2018-06-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-02-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	normal saline	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.
Study Group	Bupivacaine-epinephrine	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.

Primary Outcome Measures

Name	Time	Method
Postoperative agitation	9:00 AM next morning	It will be assessed with Riker Sedation-Agitation Scale (SAS)

Trial Locations

Locations (1)

Lumbini Medical College; 🇳🇵 Tansen, Palpa, Nepal