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

NCT ID: NCT02751268

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Emergence Agitation Pain

Keywords

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infraorbital nerve block infratrochlear nerve block septorhinoplasty general anesthesia postoperative analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control

placebo for the realization of infraorbital and infratrochlear block

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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

Ropivacaine

ropivacaine for the realization of infraorbital and infratrochlear block

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

Interventions

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Normal Saline

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

Intervention Type DRUG

Ropivacaine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Armed Forces Hampyeong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hoon Choi

M.D. Department of Anesthesiology and Pain Medicine, Armed Forces Hampyeong Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hoon Choi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Armed Forces Hampyeong Hostpital

Locations

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Armed Forces Hampyeong Hospital

Geumgyeri, Haebo-myeon, Hampyeong-gun, Jeollanam-do, South Korea

Site Status

Countries

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South Korea

References

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Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.

Reference Type BACKGROUND
PMID: 25729495 (View on PubMed)

Boselli E, Bouvet L, Augris-Mathieu C, Begou G, Diot-Junique N, Rahali N, Vertu-Ciolino D, Gerard C, Pivot C, Disant F, Allaouchiche B. Infraorbital and infratrochlear nerve blocks combined with general anaesthesia for outpatient rhinoseptoplasty: A prospective randomised, double-blind, placebo-controlled study. Anaesth Crit Care Pain Med. 2016 Feb;35(1):31-36. doi: 10.1016/j.accpm.2015.09.002. Epub 2015 Nov 5.

Reference Type BACKGROUND
PMID: 26549134 (View on PubMed)

Other Identifiers

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AFMC-16028-IRB-16-021

Identifier Type: -

Identifier Source: org_study_id