Nasal FractureNCT03733275
Efficacy of L/A Spray andL/A-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
A study testing Lidocaine in people with Nasal Fracture, run by The Catholic University of Korea at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Fracture
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 3 Dec 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients scheduled to receive nasal reduction surgery under general aensthesia
Who cannot join
- concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul St.Mary's Hospital
Seoul, Seocho-gu, 07651
Seoul St.Mary's Hospital
Seoul, Seocho-gu, 137-701
About this study
Official title: 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.
Read the 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).
- Conditions
- Nasal Fracture
- Being tested
- Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called bupivacaine
for experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing
| Study group | Role | What they receive |
|---|---|---|
| local anesthetic group | Experimental | local aensthetic group receive preopetaive lidocaine spray and lidocaine-bupivacine mixture-soaked nasal pacing after nasal reduction surgery Receives: Drug: Lidocaine |
| control group | Placebo comparator | control group receive preoperative normal saline spray and normal saline-soaked nasal packing after nasal reduction surgery Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain in recovery room
Using VAS, postoperative pain is measured.
Measured: immediately after surgery
Secondary outcomes (1)
rescue analgesics in recovery room
Fentanyl iv injection for pain control is checked.
Measured: 1 hr after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start3 Dec 2018
- Primary completion30 Apr 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
- Investigators
- Young Eun Moon, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733275
- Sponsor's protocol ID
- yemoon
- Status last verified
- Feb 2021
- First submitted
- 5 Nov 2018
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Lidocaine Spray and Local Aensthetics-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
- ClinicalTrials.gov ID
- NCT03733275
- Acronym / sponsor ID
- yemoon
- Conditions
- Nasal Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local anesthetic group | Experimental | Drug: Lidocainelocal aensthetic group receive preopetaive lidocaine spray and lidocaine-bupivacine mixture-soaked nasal pacing after nasal reduction surgery |
| control group | Placebo comparator | Drug: Lidocainecontrol group receive preoperative normal saline spray and normal saline-soaked nasal packing after nasal reduction surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to receive nasal reduction surgery under general aensthesia
Key exclusion criteria (1 listed)
- concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: bupivacainefor experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing | Drug | control group, local anesthetic group |
Primary outcome
postoperative pain in recovery room
Time frame: immediately after surgery
Using VAS, postoperative pain is measured.
1 secondary outcome
rescue analgesics in recovery room
Time frame: 1 hr after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Eun Moon, MD principal investigator
Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Nasal Fracture, run by The Catholic University of Korea at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain in recovery room (time frame: immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.