Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

NCT ID: NCT03427502

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bupivacaine-epinephrine

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

normal saline

Interventions

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

Intervention Type: DRUG

normal saline

normal saline

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumbini Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lumbini Medical College

Tānsen, Palpa, Nepal

Countries

Nepal

Other Identifiers

139

Identifier Type: -

Identifier Source: org_study_id