Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

L

Lumbini Medical College

Status

Completed

Conditions

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

Treatments

Drug: Bupivacaine-epinephrine
Drug: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03427502
139

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

Study Group
Experimental group
Description:
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.
Treatment:
Drug: Bupivacaine-epinephrine
Control Group
Placebo Comparator group
Description:
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.
Treatment:
Drug: normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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