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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02751268
Enrollment
66
Registered
2016-04-26
Start date
2016-04-30
Completion date
2017-03-31
Last updated
2016-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation, Pain

Keywords

infraorbital nerve block, infratrochlear nerve block, septorhinoplasty, general anesthesia, postoperative analgesia

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.

Interventions

DRUGNormal Saline

Bilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline

DRUGRopivacaine

Bilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine

Sponsors

Armed Forces Hampyeong Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emergence agitation2 hours after surgeryEmergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7

Secondary

MeasureTime frameDescription
Pain intensity2, 8, 24, 48 hours after surgery0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable
Patient satisfaction48 hours after surgery1-5 scale (1: very unsatisfactory, 2: rather unsatisfactory, 3: fair, 4: rather satisfactory, 5: very satisfactory)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026