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

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ClinicalTrials.gov Identifier: NCT02751268
Recruitment Status : Unknown
Verified April 2016 by Hoon Choi, Armed Forces Hampyeong Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 26, 2016
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hoon Choi, Armed Forces Hampyeong Hospital

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. 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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751268


Locations
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Korea, Republic of
Armed Forces Hampyeong Hospital
Geumgye-ri, Haebo-myeon, Hampyeong-gun, Jeollanam-do, Korea, Republic of, 57116
Sponsors and Collaborators
Armed Forces Hampyeong Hospital
Investigators
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Principal Investigator: Hoon Choi, M.D. Armed Forces Hampyeong Hostpital

Publications:
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Responsible Party: Hoon Choi, M.D. Department of Anesthesiology and Pain Medicine, Armed Forces Hampyeong Hospital, Armed Forces Hampyeong Hospital
ClinicalTrials.gov Identifier: NCT02751268     History of Changes
Other Study ID Numbers: AFMC-16028-IRB-16-021
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hoon Choi, Armed Forces Hampyeong Hospital:
infraorbital nerve block
infratrochlear nerve block
septorhinoplasty
general anesthesia
postoperative analgesia

Additional relevant MeSH terms:
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Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents