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Clinical Trials/NCT03427502
NCT03427502
Completed
Not Applicable

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

Lumbini Medical College1 site in 1 country100 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
normal saline
Conditions
Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia
Sponsor
Lumbini Medical College
Enrollment
100
Locations
1
Primary Endpoint
Postoperative agitation
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
February 28, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lumbini Medical College
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Control Group

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.

Intervention: normal saline

Study Group

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.

Intervention: Bupivacaine-epinephrine

Outcomes

Primary Outcomes

Postoperative agitation

Time Frame: 9:00 AM next morning

It will be assessed with Riker Sedation-Agitation Scale (SAS)

Study Sites (1)

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