NCT02751268

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

April 24, 2016

Last Update Submit

April 27, 2016

Conditions

Emergence AgitationPain

Keywords

infraorbital nerve blockinfratrochlear nerve blockseptorhinoplastygeneral anesthesiapostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Emergence agitation

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

    2 hours after surgery

Secondary Outcomes (2)

  • Pain intensity

    2, 8, 24, 48 hours after surgery

  • Patient satisfaction

    48 hours after surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

placebo for the realization of infraorbital and infratrochlear block

Drug: Normal Saline

Ropivacaine

ACTIVE COMPARATOR

ropivacaine for the realization of infraorbital and infratrochlear block

Drug: Ropivacaine

Interventions

Normal SalineDRUG

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

Control
RopivacaineDRUG

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

Ropivacaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Septorhinoplasty
  • American Society of Anesthesiologists (ASA) classification I-II
  • Written informed consent

You may not qualify if:

  • ASA classification greater than III
  • Allergy to ropivacaine
  • Incapability to give consent
  • Chronic pain
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Hampyeong Hospital

Geumgyeri, Haebo-myeon, Hampyeong-gun, Jeollanam-do, 57116, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 25729495BACKGROUND

  • 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.

    PMID: 26549134BACKGROUND

MeSH Terms

Conditions

Emergence DeliriumPain

Interventions

Saline SolutionRopivacaine

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Hoon Choi, M.D.

    Armed Forces Hampyeong Hostpital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Department of Anesthesiology and Pain Medicine, Armed Forces Hampyeong Hospital

Study Record Dates

First Submitted

April 24, 2016

First Posted

April 26, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 29, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)