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

Sponsor
The Catholic University of Korea (Other)
Overall Status
Completed
CT.gov ID
NCT03733275
Collaborator
(none)
33
Enrollment
2
Locations
2
Arms
5.9
Actual Duration (Months)
16.5
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Preoperative Lidocaine Spray and Local Aensthetics-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
Actual Study Start Date :
Dec 3, 2018
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
May 31, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pain in recovery room [immediately after surgery]

      Using VAS, postoperative pain is measured.

    Secondary Outcome Measures

    1. rescue analgesics in recovery room [1 hr after surgery]

      Fentanyl iv injection for pain control is checked.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients scheduled to receive nasal reduction surgery under general aensthesia
    Exclusion Criteria:
    • concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul St.Mary's Hospital Seoul Seocho-gu Korea, Republic of 07651
    2 Seoul St.Mary's Hospital Seoul Seocho-gu Korea, Republic of 137-701

    Sponsors and Collaborators

    • The Catholic University of Korea

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Young Eun Moon, Associate professor, The Catholic University of Korea
    ClinicalTrials.gov Identifier:
    NCT03733275
    Other Study ID Numbers:
    • yemoon
    First Posted:
    Nov 7, 2018
    Last Update Posted:
    Feb 4, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Pain, Postoperative
    Lidocaine
    Bupivacaine

    Study Results

    No Results Posted as of Feb 4, 2021