Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

Nasal Polyps Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427502
• Other study ID #: 139
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2020
• Source: Lumbini Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• normal saline
normal saline

Locations

Country	Name	City	State
Nepal	Lumbini Medical College	Tansen	Palpa

Sponsors (1)

Lead Sponsor	Collaborator
Lumbini Medical College

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	Postoperative agitation	It will be assessed with Riker Sedation-Agitation Scale (SAS)	9:00 AM next morning