Efficacy of L/A Spray andL/A-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction

NCT ID: NCT03733275

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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To investigate the treatment of postoperative pain after nasal closed reduction surgery, we plan to investigate the effect of preoperative lidocaine spray and lidocaine-bupivacaine mixture-soaked nasal packing for the patinets undergoing nasal closed reduction under general aensthesia, compaing to the control group (normal saline spray and normal saline-soaked nasal packing).

Conditions

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Nasal Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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local anesthetic group

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

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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

control group

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

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

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

Interventions

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Lidocaine

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

Intervention Type DRUG

Other Intervention Names

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bupivacaine

Eligibility Criteria

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Inclusion Criteria

* patients scheduled to receive nasal reduction surgery under general aensthesia

Exclusion Criteria

* concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Young Eun Moon

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Eun Moon, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Seoul St.Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status

Seoul St.Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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yemoon

Identifier Type: -

Identifier Source: org_study_id

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