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

Primary Purpose

Emergence Agitation, Pain

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Normal Saline
Ropivacaine
Sponsored by
Armed Forces Hampyeong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Agitation focused on measuring infraorbital nerve block, infratrochlear nerve block, septorhinoplasty, general anesthesia, postoperative analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Armed Forces Hampyeong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Ropivacaine

Arm Description

placebo for the realization of infraorbital and infratrochlear block

ropivacaine for the realization of infraorbital and infratrochlear block

Outcomes

Primary Outcome Measures

Emergence agitation
Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7

Secondary Outcome Measures

Pain intensity
0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable
Patient satisfaction
1-5 scale (1: very unsatisfactory, 2: rather unsatisfactory, 3: fair, 4: rather satisfactory, 5: very satisfactory)

Full Information

First Posted
April 24, 2016
Last Updated
April 27, 2016
Sponsor
Armed Forces Hampyeong Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02751268
Brief Title
Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty
Official Title
Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Hampyeong Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation, Pain
Keywords
infraorbital nerve block, infratrochlear nerve block, septorhinoplasty, general anesthesia, postoperative analgesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
placebo for the realization of infraorbital and infratrochlear block
Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
ropivacaine for the realization of infraorbital and infratrochlear block
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Bilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Bilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine
Primary Outcome Measure Information:
Title
Emergence agitation
Description
Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7
Time Frame
2 hours after surgery
Secondary Outcome Measure Information:
Title
Pain intensity
Description
0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable
Time Frame
2, 8, 24, 48 hours after surgery
Title
Patient satisfaction
Description
1-5 scale (1: very unsatisfactory, 2: rather unsatisfactory, 3: fair, 4: rather satisfactory, 5: very satisfactory)
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoon Choi, M.D.
Organizational Affiliation
Armed Forces Hampyeong Hostpital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Forces Hampyeong Hospital
City
Geumgye-ri
State/Province
Haebo-myeon, Hampyeong-gun, Jeollanam-do
ZIP/Postal Code
57116
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25729495
Citation
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.
Results Reference
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PubMed Identifier
26549134
Citation
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.
Results Reference
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Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty

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