RhinoplastyPhase 4NCT03457116

Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

A Phase 4 study testing Norco and NSAID in people with Rhinoplasty and Non-steroidal Ant Inflammatory Drugs, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Rhinoplasty, Non-steroidal Ant Inflammatory Drugs, Opioid Use
What is being tested?: Norco and NSAID
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 30 Jan 2018to 2 Nov 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Who cannot join

Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Medical Center
New York, New York, 10016

Other trials in United States

About this study

Official title: Narcotics vs Non-steroidal Ant Inflammatory Drugs Post-operative Analgesia in Outpatient Rhinoplasty

The purpose of this study is to compare the efficacy and safety of oral opiate pain medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative rhinoplasty pain. This study will also evaluate potential contributing factors affecting the efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used for post-operative pain. The study will then compare which is more effective in controlling post operative pain.

Conditions: Rhinoplasty, Non-steroidal Ant Inflammatory Drugs, Opioid Use
Being tested: Norco, NSAID

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NorcoDrug
20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
NSAIDDrug
Ibuprofen 400mg for post-operative pain

Study groups in NCT03457116
Study group	Role	What they receive
NSAIDS	Active comparator	400mg of Ibuprofen Receives: Drug: NSAID
Opiates	Active comparator	Norco (hydrocodone 5mg- acetaminophen 325mg) Receives: Drug: Norco

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Pain Score
Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)
Measured: Day 0
Average Pain Score
Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)
Measured: Day 1
Average Pain Score
Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)
Measured: Day 7
Average Post-Operative Day (POD) of Medication Cessation
Self-reported via Post-Operative Pain Management Survey
Measured: Day 7

Secondary outcomes (1)

Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain
Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 20182 Nov 2020

First posted7 Mar 2018
Study start30 Jan 2018
Primary completion2 Nov 2020
Study completion2 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RhinoplastyStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03457116
Sponsor's protocol ID: 17-01839
Status last verified: Oct 2021
First submitted: 1 Mar 2018
Last updated: 23 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries
Enrolling by invitationObservational study
Screen Addiction and Postoperative Pain
Pain, Postoperative
Active, not recruitingPhase 1
A Prospective Randomized Double Blind Trial to Assess the Effect of a Single Preoperative Dose of Gabapentin on Postoperative Opioid Consumption in Patients Undergoing Rhinoplasty
Pain, Postoperative, Opioid Use
RecruitingPhase 2
Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia
Pain, Postoperative
Active, not recruiting
Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty
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All Rhinoplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Narcotics vs Non-steroidal Ant Inflammatory Drugs Post-operative Analgesia in Outpatient Rhinoplasty
ClinicalTrials.gov ID: NCT03457116
Acronym / sponsor ID: 17-01839
Conditions: Rhinoplasty, Non-steroidal Ant Inflammatory Drugs, Opioid Use
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 30 Jan 2018 (actual)
Primary completion: 2 Nov 2020 (actual)
Study completion: 2 Nov 2020 (actual)
First posted: 7 Mar 2018 (actual)
Results: Posted 23 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NSAIDS	Active comparator	Drug: NSAID400mg of Ibuprofen
Opiates	Active comparator	Drug: NorcoNorco (hydrocodone 5mg- acetaminophen 325mg)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Key exclusion criteria (4 listed)

Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.

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
Norco20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)	Drug	Opiates
NSAIDIbuprofen 400mg for post-operative pain	Drug	NSAIDS

Primary outcome

Average Pain Score
Time frame: Day 0
Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)
Average Pain Score
Time frame: Day 1
Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)
Average Pain Score
Time frame: Day 7
Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)
Average Post-Operative Day (POD) of Medication Cessation
Time frame: Day 7
Self-reported via Post-Operative Pain Management Survey

1 secondary outcome

Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain
Time frame: Day 7

Results and safety

Results posted to the registry on 23 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NSAIDS	41	41
Opiates	29	29

Primary outcome: Average Pain Score

Time frame: Day 0. Mean (Standard Deviation). Unit: score on a scale

Measure	NSAIDS n = 41	Opiates n = 29
Value	2.54 (1.57)	3.14 (1.75)

Primary outcome: Average Pain Score

Time frame: Day 1. Mean (Standard Deviation). Unit: score on a scale

Measure	NSAIDS n = 41	Opiates n = 29
Value	1.84 (1.29)	2.46 (1.90)

Primary outcome: Average Pain Score

Time frame: Day 7. Mean (Standard Deviation). Unit: score on a scale

Measure	NSAIDS n = 41	Opiates n = 29
Value	3.29 (2.14)	3.14 (2.12)

Primary outcome: Average Post-Operative Day (POD) of Medication Cessation

Time frame: Day 7. Mean (Standard Deviation). Unit: days

Measure	NSAIDS n = 41	Opiates n = 29
Value	4.73 (1.57)	4.28 (2.23)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NSAIDS	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Opiates	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.

Related trials for Rhinoplasty

Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries
Enrolling by invitationObservational study
Screen Addiction and Postoperative Pain
Pain, Postoperative
Active, not recruitingPhase 1
A Prospective Randomized Double Blind Trial to Assess the Effect of a Single Preoperative Dose of Gabapentin on Postoperative Opioid Consumption in Patients Undergoing Rhinoplasty
Pain, Postoperative, Opioid Use
RecruitingPhase 2
Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia
Pain, Postoperative
Active, not recruiting
Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty
Rhinoplasty Techniques

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.

Judy Lee, MD principal investigator

NYU Langone

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Norco and NSAID in people with Rhinoplasty and Non-steroidal Ant Inflammatory Drugs, run by NYU Langone Health at 1 site in United States.

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 4 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Average Pain Score (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03457116.

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 23 Nov 2021.