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Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

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ClinicalTrials.gov Identifier: NCT03427502
Recruitment Status : Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
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 Drug: Bupivacaine-epinephrine Drug: normal saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries With Nasal Packs Under General Anesthesia: A Double Blind Randomized Control Trial
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: 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.

Drug: Bupivacaine-epinephrine
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

Placebo Comparator: 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.

Drug: normal saline
normal saline




Primary Outcome Measures :
  1. Postoperative agitation [ Time Frame: After extubation before leaving operation table, an average of 10 minutes ]
    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.

  2. Postoperative agitation [ Time Frame: 30 minutes after first score. ]
    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.

  3. Postoperative agitation [ Time Frame: 9:00 AM next morning ]
    It will be assessed with Riker Sedation-Agitation Scale (SAS)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427502


Locations
Nepal
Lumbini Medical College Not yet recruiting
Tansen, Palpa, Nepal, 32500
Contact: Anup Acharya, MS (ENT)    977 9802625484    anupent@gmail.com   
Contact: Shreyashi Aryal, MD (Obsterrics and Gynecology)    977 9813595444    shreyashiaryal@gmail.com   
Sponsors and Collaborators
Lumbini Medical College

Responsible Party: Lumbini Medical College
ClinicalTrials.gov Identifier: NCT03427502     History of Changes
Other Study ID Numbers: LumbiniMC
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All data except patients name and address may be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lumbini Medical College:
general anesthesia
nasal surgery
anterior ehtmoidal nerve block
bupivacaine
postoperative confusion

Additional relevant MeSH terms:
Psychomotor Agitation
Nasal Polyps
Confusion
Sinusitis
Chronic Disease
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Bupivacaine
Epinephrine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists