Pain, PostoperativePhase 2NCT03584152
Postoperative Pain Management in Rhinoplasty
A Phase 2 study testing Norco 5Mg-325Mg Tablet, Tylenol 325Mg Caplet and Ibuprofen 200 mg in people with Pain, Postoperative, run by Stanford University at 1 site in United States.
Trial summary
The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Norco 5Mg-325Mg Tablet, Tylenol 325Mg Caplet and Ibuprofen 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to 17 Jul 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years
- Able to speak and understand english.
- Undergoing rhinoplasty for cosmetic purposes
- Undergoing rhinoplasty for treatment of nasal obstruction
Who cannot join
- Less than 18 years of age
- Cannot speak and understand english
- Patients who have undergone nasal surgery in the past
- Patients not undergoing nasal surgery
- Women will be excluded if they are either pregnant or lactating as this population does not undergo nasal surgery at our center.
- Patients with any known allergies to the class of pain medications used in the study.
- Please note: Any person interested in this clinical trial should contact the Facial Plastic and Reconstructive Surgery clinic at (650) 736 - 3223 to schedule a consultation with Dr. Sam P. Most to assess their eligibility for the trial. Please note, enrolling in the clinical trial will not entitle the participant to a waiver of charges associated with undergoing nasal surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Facial Plastic and Reconstructive Surgery Clinic
Stanford, California, 94305
About this study
Official title: Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial
The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications .
Additionally, the study will also seek to track:
- The total number of pills each patients consume from the prescribed 5 day regimen.
- Any associated side effects.
- Additional pain medications prescribed in case of inadequate pain control, postoperatively.
Read the detailed description
From this study, the investigators hope to learn the following:
- Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs?
- If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for?
- What are the common side effect profiles of the included drugs?
In light of the current opioid epidemic in the country, it is important the the physicians explore the utility of drugs other than opioids for adequate postoperative pain management. Also, reducing the dosage and/or number of prescribed opioid drugs lessens the propensity for misuse of physician prescribed opioid medications.
- Conditions
- Pain, Postoperative
- Being tested
- Norco 5Mg-325Mg Tablet, Tylenol 325Mg Caplet, Ibuprofen 200 mg
- Keywords
- Postoperative pain, Rhinoplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norco 5Mg-325Mg TabletDrug
Also called Lortab, Vicodin, Hycet
Opioid Analgesics
Tylenol 325Mg CapletDrug
Also called Acetaminophen
Non opioid analgesics
Ibuprofen 200 mgDrug
Also called Advil, Motrin
Non opioid analgesics
| Study group | Role | What they receive |
|---|---|---|
| Drug Arm A | Active comparator | Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total Receives: Drug: Norco 5Mg-325Mg Tablet |
| Drug Arm B | Active comparator | Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total. Receives: Drug: Tylenol 325Mg Caplet; Drug: Ibuprofen 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain)
Self reported pain intensity at every prescribed dose averaged over a period of 5 days.
Measured: 5 days post-operative [up to approximately 5 weeks post-baseline]
Secondary outcomes (10)
Number of Study Drugs (Doses) Utilized
Use of any study medication, excluding tramadol.
Measured: 5 days
Number of Tramadol Doses Utilized
Measured: 5 days
Number Patients Who Reported Adequate Pain Control
Measured: 5 days
Side Effects of Pain Medications
Self reported side effects of prescribed medications according to response options. Participants may have reported more than one side-effect. Commonly experienced medication side-effects would not necessarily be considered to be adverse events.
Measured: 5 days
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire
The SCHNOS-O (obstructive) and SCHNOS-C (Cosmesis) scores were rated from 0 to 100 (higher scores correspond to worse obstruction or cosmesis). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Measured: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Visual Analog Scale-Functional (VAS-F)
Patient's perceived severity of their nasal obstruction was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'no nasal obstruction' and '10' indicated 'worst possible nasal obstruction). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Measured: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Visual Analog Scale-Aesthetic (VAS-A)
Patient's perceived aesthetic appearance was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'completely dissatisfied with nasal appearance' and '10' indicated 'the highest possible satisfaction with nasal appearance'). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Measured: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Eyelid Edema Score
Physician-assessed grading of eyelid edema. Score range: 0 to 4; higher numbers indicating more severe swelling.
Measured: Post-operative day 7
Ecchymosis Score
Physician-assessed grading of periorbital ecchymosis extension. Score range: 0 to 4; higher numbers indicating more severe ecchymosis.
Measured: Post-operative day 7
Subconjunctival Hemorrhage Score
Physician-assessed grading of subconjunctival hemorrhage. Score range: 0 to 2; higher numbers indicating more severe hemorrhage.
Measured: Post-operative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start9 Aug 2019
- Primary completion14 Nov 2024
- Study completion17 Jul 2025
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam P. Most, Stanford University
- Investigators
- SAM P Most, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584152
- Sponsor's protocol ID
- 46945
- Status last verified
- Nov 2025
- First submitted
- 27 Jun 2018
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel S, Sturm A, Bobian M, Svider PF, Zuliani G, Kridel R. Opioid Use by Patients After Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):24-30. doi: 10.1001/jamafacial.2017.1034.
PubMed 29121158
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03584152
- Acronym / sponsor ID
- 46945
- Conditions
- Pain, Postoperative
- Keywords
- Postoperative pain, Rhinoplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications .
Additionally, the study will also seek to track:
- The total number of pills each patients consume from the prescribed 5 day regimen.
- Any associated side effects.
- Additional pain medications prescribed in case of inadequate pain control, postoperatively.
Detailed description
From this study, the investigators hope to learn the following:
- Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs?
- If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for?
- What are the common side effect profiles of the included drugs?
In light of the current opioid epidemic in the country, it is important the the physicians explore the utility of drugs other than opioids for adequate postoperative pain management. Also, reducing the dosage and/or number of prescribed opioid drugs lessens the propensity for misuse of physician prescribed opioid medications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Arm A | Active comparator | Drug: Norco 5Mg-325Mg TabletNorco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total |
| Drug Arm B | Active comparator | Drug: Tylenol 325Mg Caplet, Drug: Ibuprofen 200 mgTylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum age of 18 years
- Able to speak and understand english.
- Undergoing rhinoplasty for cosmetic purposes
- Undergoing rhinoplasty for treatment of nasal obstruction
Key exclusion criteria (7 listed)
- Less than 18 years of age
- Cannot speak and understand english
- Patients who have undergone nasal surgery in the past
- Patients not undergoing nasal surgery
- Women will be excluded if they are either pregnant or lactating as this population does not undergo nasal surgery at our center.
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 |
|---|---|---|
| Norco 5Mg-325Mg TabletAlso: Lortab, Vicodin, HycetOpioid Analgesics | Drug | Drug Arm A |
| Tylenol 325Mg CapletAlso: AcetaminophenNon opioid analgesics | Drug | Drug Arm B |
| Ibuprofen 200 mgAlso: Advil, MotrinNon opioid analgesics | Drug | Drug Arm B |
Primary outcome
Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain)
Time frame: 5 days post-operative [up to approximately 5 weeks post-baseline]
Self reported pain intensity at every prescribed dose averaged over a period of 5 days.
10 secondary outcomes
Number of Study Drugs (Doses) Utilized
Time frame: 5 days
Number of Tramadol Doses Utilized
Time frame: 5 days
Number Patients Who Reported Adequate Pain Control
Time frame: 5 days
Side Effects of Pain Medications
Time frame: 5 days
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire
Time frame: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Visual Analog Scale-Functional (VAS-F)
Time frame: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Visual Analog Scale-Aesthetic (VAS-A)
Time frame: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Eyelid Edema Score
Time frame: Post-operative day 7
Ecchymosis Score
Time frame: Post-operative day 7
Subconjunctival Hemorrhage Score
Time frame: Post-operative day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29121158Patel S, Sturm A, Bobian M, Svider PF, Zuliani G, Kridel R. Opioid Use by Patients After Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):24-30. doi: 10.1001/jamafacial.2017.1034.
- Individual participant dataSharing planned: No
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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.
SAM P Most, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Norco 5Mg-325Mg Tablet, Tylenol 325Mg Caplet and Ibuprofen 200 mg in people with Pain, Postoperative, run by Stanford University 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 4 inclusion and 7 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 3 Dec 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Nov 2025). 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?
Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain) (time frame: 5 days post-operative [up to approximately 5 weeks post-baseline]). 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 NCT03584152, which also lists 1 linked publication.
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 3 Dec 2025.