search
Back to results

Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Bupivacaine-epinephrine
normal saline
Sponsored by
Lumbini Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia focused on measuring general anesthesia, nasal surgery, anterior ehtmoidal nerve block, bupivacaine, postoperative confusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lumbini Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Group

Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2018
Last Updated
September 10, 2020
Sponsor
Lumbini Medical College
search

1. Study Identification

Unique Protocol Identification Number
NCT03427502
Brief Title
Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumbini Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
general anesthesia, nasal surgery, anterior ehtmoidal nerve block, bupivacaine, postoperative confusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-epinephrine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
normal saline
Primary Outcome Measure Information:
Title
Postoperative agitation
Description
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.
Time Frame
After extubation before leaving operation table, an average of 10 minutes
Title
Postoperative agitation
Description
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.
Time Frame
30 minutes after first score.
Title
Postoperative agitation
Description
It will be assessed with Riker Sedation-Agitation Scale (SAS)
Time Frame
9:00 AM next morning

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Lumbini Medical College
City
Tansen
State/Province
Palpa
ZIP/Postal Code
32500
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
All data except patients name and address may be shared.

Learn more about this trial

Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

We'll reach out to this number within 24 hrs