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

Sponsor

Armed Forces Hampyeong Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02751268

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emergence Agitation Pain	Drug: Normal Saline Drug: Ropivacaine	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty: A Randomized Controlled Trial

Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control placebo for the realization of infraorbital and infratrochlear block	Drug: Normal Saline Bilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline
Active Comparator: Ropivacaine ropivacaine for the realization of infraorbital and infratrochlear block	Drug: Ropivacaine Bilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine

Arm

Intervention/Treatment

Placebo Comparator: Control

placebo for the realization of infraorbital and infratrochlear block

Drug: Normal Saline

Bilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline

Active Comparator: Ropivacaine

ropivacaine for the realization of infraorbital and infratrochlear block

Drug: Ropivacaine

Bilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine

Outcome Measures

Primary Outcome Measures

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

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)