Back to resultsEfficacy of L/A Spray andL/A-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
Primary Purpose
Nasal Fracture
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Fracture
Eligibility Criteria
Inclusion Criteria:
- patients scheduled to receive nasal reduction surgery under general aensthesia
Exclusion Criteria:
- concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)
Sites / Locations
- Seoul St.Mary's Hospital
- Seoul St.Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
local anesthetic group
control group
Arm Description
local aensthetic group receive preopetaive lidocaine spray and lidocaine-bupivacine mixture-soaked nasal pacing after nasal reduction surgery
control group receive preoperative normal saline spray and normal saline-soaked nasal packing after nasal reduction surgery
Outcomes
Primary Outcome Measures
postoperative pain in recovery room
Using VAS, postoperative pain is measured.
Secondary Outcome Measures
rescue analgesics in recovery room
Fentanyl iv injection for pain control is checked.
Full Information
NCT ID
NCT03733275
First Posted
November 5, 2018
Last Updated
February 2, 2021
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT03733275
Brief Title
Efficacy of L/A Spray andL/A-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
Official Title
Efficacy of Preoperative Lidocaine Spray and Local Aensthetics-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
local anesthetic group
Arm Type
Experimental
Arm Description
local aensthetic group receive preopetaive lidocaine spray and lidocaine-bupivacine mixture-soaked nasal pacing after nasal reduction surgery
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
control group receive preoperative normal saline spray and normal saline-soaked nasal packing after nasal reduction surgery
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
bupivacaine
Intervention Description
for experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing
Primary Outcome Measure Information:
Title
postoperative pain in recovery room
Description
Using VAS, postoperative pain is measured.
Time Frame
immediately after surgery
Secondary Outcome Measure Information:
Title
rescue analgesics in recovery room
Description
Fentanyl iv injection for pain control is checked.
Time Frame
1 hr after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients scheduled to receive nasal reduction surgery under general aensthesia
Exclusion Criteria:
concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Eun Moon, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St.Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
07651
Country
Korea, Republic of
Facility Name
Seoul St.Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of L/A Spray andL/A-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
We'll reach out to this number within 24 hrs