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

April 27, 2016 updated by: Hoon Choi, Armed Forces Hampyeong Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Haebo-myeon, Hampyeong-gun, Jeollanam-do
      • Geumgye-ri, Haebo-myeon, Hampyeong-gun, Jeollanam-do, Korea, Republic of, 57116
        • Armed Forces Hampyeong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence agitation
Time Frame: 2 hours after surgery
Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7
2 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Hampyeong Hospital

Investigators

  • Principal Investigator: Hoon Choi, M.D., Armed Forces Hampyeong Hostpital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

April 24, 2016

First Submitted That Met QC Criteria

April 24, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFMC-16028-IRB-16-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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