Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty

Phase 4

• Conditions: Emergence Agitation; Pain
• Interventions: Drug: Normal Saline; Drug: Ropivacaine

• Registration Number: NCT02751268
• Lead Sponsor: Armed Forces Hampyeong Hospital

Brief Summary

The purpose of this study is to determine whether bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty are effective in preventing emergence agitation.

Detailed Description

Emergence agitation is a postanesthetic phenomenon characterized as confusion, disorientation and violent behavior. Although its etiology is not well understood, risk factors associated with the condition include pain and ENT (ear, nose and throat) surgery. Bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty is effective in treating postoperative pain. The investigators have designed this study to evaluate the effect of infraorbital and infratrochlear nerve block on emergence agitation in patients undergoing septorhinoplasty.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-24
• Study First Submitted QC: 2016-04-24
• Study First Posted: 2016-04-26
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-29
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Septorhinoplasty
• American Society of Anesthesiologists (ASA) classification I-II
• Written informed consent

Exclusion Criteria

• ASA classification greater than III
• Allergy to ropivacaine
• Incapability to give consent
• Chronic pain
• Coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal Saline	placebo for the realization of infraorbital and infratrochlear block
Ropivacaine	Ropivacaine	ropivacaine for the realization of infraorbital and infratrochlear block

Primary Outcome Measures

Name	Time	Method
Emergence agitation	2 hours after surgery	Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7

Secondary Outcome Measures

Name	Time	Method
Pain intensity	2, 8, 24, 48 hours after surgery	0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable
Patient satisfaction	48 hours after surgery	1-5 scale (1: very unsatisfactory, 2: rather unsatisfactory, 3: fair, 4: rather satisfactory, 5: very satisfactory)

Trial Locations

Locations (1)

Armed Forces Hampyeong Hospital; 🇰🇷 Geumgye-ri, Haebo-myeon, Hampyeong-gun, Jeollanam-do, Korea, Republic of