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

February 2, 2021 updated by: Young Eun Moon, The Catholic University of Korea

Efficacy of Preoperative Lidocaine Spray and Local Aensthetics-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of, 07651
        • Seoul St.Mary's Hospital
      • Seoul, Seocho-gu, Korea, Republic of, 137-701
        • Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled to receive nasal reduction surgery under general aensthesia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: local anesthetic group
local aensthetic group receive preopetaive lidocaine spray and lidocaine-bupivacine mixture-soaked nasal pacing after nasal reduction surgery
Drug: Lidocaine
for experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing
Other Names:
  • bupivacaine
Placebo Comparator: control group
control group receive preoperative normal saline spray and normal saline-soaked nasal packing after nasal reduction surgery
Drug: Lidocaine
for experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing
Other Names:
  • bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain in recovery room
Time Frame: immediately after surgery
Using VAS, postoperative pain is measured.
immediately after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rescue analgesics in recovery room
Time Frame: 1 hr after surgery
Fentanyl iv injection for pain control is checked.
1 hr after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Young Eun Moon, MD, Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yemoon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nasal Fracture

Clinical Trials on Lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe