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Clinical Trials/NCT02751268
NCT02751268
Unknown
Phase 4

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

Armed Forces Hampyeong Hospital1 site in 1 country66 target enrollmentApril 2016

Overview

Phase
Phase 4
Intervention
Normal Saline
Conditions
Emergence Agitation
Sponsor
Armed Forces Hampyeong Hospital
Enrollment
66
Locations
1
Primary Endpoint
Emergence agitation
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
March 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Armed Forces Hampyeong Hospital
Responsible Party
Principal Investigator
Principal Investigator

Hoon Choi

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

Armed Forces Hampyeong Hospital

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

Arms & Interventions

Control

placebo for the realization of infraorbital and infratrochlear block

Intervention: Normal Saline

Ropivacaine

ropivacaine for the realization of infraorbital and infratrochlear block

Intervention: Ropivacaine

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Pain intensity(2, 8, 24, 48 hours after surgery)
  • Patient satisfaction(48 hours after surgery)

Study Sites (1)

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