NCT03733275

Brief Summary

This study is perfored to investigate the efficacy of preoperative lidocaine spray and lidocaine-bupivacaine mixture-soaked nasal packing for acute postoperative pain after nasal closed reduction surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

December 3, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

November 5, 2018

Last Update Submit

February 2, 2021

Conditions

Nasal Fracture

Outcome Measures

Primary Outcomes (1)

  • postoperative pain in recovery room

    Using VAS, postoperative pain is measured.

    immediately after surgery

Secondary Outcomes (1)

  • rescue analgesics in recovery room

    1 hr after surgery

Study Arms (2)

local anesthetic group

EXPERIMENTAL

local aensthetic group receive preopetaive lidocaine spray and lidocaine-bupivacine mixture-soaked nasal pacing after nasal reduction surgery

Drug: Lidocaine

control group

PLACEBO COMPARATOR

control group receive preoperative normal saline spray and normal saline-soaked nasal packing after nasal reduction surgery

Drug: Lidocaine

Interventions

LidocaineDRUG

for experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing

Also known as: bupivacaine
control grouplocal anesthetic group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled to receive nasal reduction surgery under general aensthesia

You may not qualify if:

  • concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul St.Mary's Hospital

Seoul, Seocho-gu, 07651, South Korea

Location

Seoul St.Mary's Hospital

Seoul, Seocho-gu, 137-701, South Korea

Location

MeSH Terms

Interventions

LidocaineBupivacaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Young Eun Moon, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

December 3, 2018

Primary Completion

April 30, 2019

Study Completion

May 31, 2019

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

KR(2)