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NCT02751268 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02751268
Other study ID # AFMC-16028-IRB-16-021
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received April 24, 2016
Last updated April 27, 2016
Start date April 2016
Est. completion date March 2017

Study information
Verified date April 2016
Source Armed Forces Hampyeong Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 66
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Normal Saline
Bilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline
• Ropivacaine
Bilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine

Locations
Country Name City State
Korea, Republic of Armed Forces Hampyeong Hospital Geumgye-ri Haebo-myeon, Hampyeong-gun, Jeollanam-do

Sponsors (1)
Lead Sponsor Collaborator
Armed Forces Hampyeong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Boselli E, Bouvet L, Augris-Mathieu C, Bégou G, Diot-Junique N, Rahali N, Vertu-Ciolino D, Gérard 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):31-6. doi: 10.1016/j.accpm.2015.09.002. Epub 2015 Nov 5. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Emergence agitation Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7 2 hours after surgery No
Secondary Pain intensity 0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable 2, 8, 24, 48 hours after surgery No
Secondary Patient satisfaction 1-5 scale (1: very unsatisfactory, 2: rather unsatisfactory, 3: fair, 4: rather satisfactory, 5: very satisfactory) 48 hours after surgery No
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