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EdemaPhase 4NCT06483204

Steroids for Rhinoplasty: Pain, Nausea, Edema and Ecchymosis

A Phase 4 study testing Medrol 4 MG Oral Tablet Includes Medrol Dosepak in people with Edema and Bruising, run by Vanderbilt University Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will be a prospective randomized study to evaluate the effect of medrol dosepaks (oral corticosteroids) on postoperative outcomes among patients undergoing rhinoplasty by Facial Plastic Surgeons at Vanderbilt. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Edema, Bruising, Nasal Obstruction
What is being tested?
Medrol 4 MG Oral Tablet Includes Medrol Dosepak
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2026to Jan 2027
Phase
Phase 4
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults at least 18 years of age who elect to undergo cosmetic or functional open primary rhinoplasty with/without osteotomies (repositioning the nasal bones)
  • No other facial plastics procedure nor sinus surgery performed simultaneously.

Who cannot join

  • revision rhinoplasty
  • diabetic patients
  • patients with an allergy to steroids
  • use of PPE implants
  • parents receiving concurrent sinus surgery
  • patients receiving biologics or preop oral steroids
Show all 10Show fewer
  • Patients that are pregnant or attempting to conceive
  • Liver failure or cirrhosis
  • Diagnosis of hypothyroidism
  • Diagnosis of glaucoma

About this study

This study will be a prospective randomized study to evaluate the effect of medrol dosepaks (oral corticosteroids) on postoperative outcomes among patients undergoing rhinoplasty by Facial Plastic Surgeons at Vanderbilt. Outcomes will include postoperative pain, nausea, and patient experience, with secondary outcomes of swelling and bruising.

Methylprednisolone is an oral corticosteroid that has been shown in multiple RCTs and is used extensively that it can significantly reduce postoperative swelling and bruising in postoperative rhinoplasty patients, however, we have not examined if those effects extend to their pain ratings, nausea, and overall patient experience. Current research on use of steroids in rhinoplasty suggests that its use may decrease pain and nausea and benefit the patients overall experience.

Minimizing complications for any surgery is of upmost importance for surgeons.. However, the benefits of oral corticosteroid use for rhinoplasty patients in the immediate post-operative period are poorly understood and practice patterns vary widely. To identify and quantify the benefits and drawbacks of oral corticosteroid use in the immediate post-operative period for primary rhinoplasty patients, pain, swelling, nausea, patient experience, and post-operative swelling will be studied.

Read the detailed description

This study will be a prospective randomized study to evaluate the effect of medrol dosepaks (oral corticosteroids) on postoperative outcomes among patients undergoing rhinoplasty by Facial Plastic Surgeons at Vanderbilt. Outcomes will include postoperative pain, nausea, and patient experience, with secondary outcomes of swelling and bruising.

Methylprednisolone is an oral corticosteroid that has been shown in multiple RCTs and is used extensively that it can significantly reduce postoperative swelling and bruising in postoperative rhinoplasty patients, however, we have not examined if those effects extend to their pain ratings, nausea, and overall patient experience. Current research on use of steroids in rhinoplasty suggests that its use may decrease pain and nausea and benefit the patients overall experience.

Minimizing complications for any surgery is of upmost importance for surgeons.. However, the benefits of oral corticosteroid use for rhinoplasty patients in the immediate post-operative period are poorly understood and practice patterns vary widely. To identify and quantify the benefits and drawbacks of oral corticosteroid use in the immediate post-operative period for primary rhinoplasty patients, pain, swelling, nausea, patient experience, and post-operative swelling will be studied.

Rhinoplasty is a popular but challenging surgery. To date, there has been very little evidence on how using medrol in the postoperative period benefits a patient in terms of pain, nausea and their overall experience. The procedure is often associated with pain, edema, bruising and postoperative nausea. We currently do use oral corticosteroids for prevention of postoperative edema and ecchymosis however, we don't have a clear idea on how use of postoperative oral steroids effects pain, nausea and the overall patient experience. This study would like to add to the body of knowledge on oral corticosteroid use in the perioperative rhinoplasty period. It would be a simple, inexpensive study that may have significant benefit for future patients and surgeons. This medication is already used and has an established safety profile. This study would simply randomize patients to treatment vs placebo to determine if any real benefit exists, in an effort to determine if this practice should be standardized and universally applied in the future, or deemed unnecessary.

The prospective participants are patients who choose to undergo elective rhinoplasty surgery with one of three attending surgeons in the division of Facial Plastic Surgery within the Department of Otolaryngology/Head and Neck Surgery at Vanderbilt University Medical Center. Patients who elect to undergo surgery will be informed of the study and offered the opportunity to volunteer to participate in person either during the preoperative clinic visit OR in the preoperative area on the day of surgery. They will be led through an informed consent process, and excluded if they meet any of the exclusion criteria. Patients will be placed in the intervention group if their MRN is even and in the no intervention group if their MRN is odd.

The patients will be met on the day of surgery by a research coordinator, who is one of the study's KSP. The research coordinator will be responsible for screening the patients and determining eligibility based on the inclusion/exclusion criteria above. All participation will be strictly voluntary and will require informed consent.

Being tested
Medrol 4 MG Oral Tablet Includes Medrol Dosepak
Medical subject headings
Edema, Contusions, Nasal Obstruction, Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications

What participants receive

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

  • Medrol 4 MG Oral Tablet Includes Medrol DosepakDrug

    Also called methylprednisolone

    Medrol tapered dosepak given to experimental arm patients to determine if there is a significant difference in pain, nausea, edema and ecchymosis outcomes in the postoperative period after a functional rhinoplasty procedure.

Study groups in NCT06483204
Study groupRoleWhat they receive
Medrol dosepak groupExperimentalFor the experimental group, they will be given a medrol dosepak which is a prescription of oral steroids taken over a week long period. The dosage of steroids decreases each day. They will also complete a study survey each day remarking on our outcomes of interest such as facial swelling, bruising, pain, and nausea.
Receives: Drug: Medrol 4 MG Oral Tablet Includes Medrol Dosepak
No medrol dosepak groupNo interventionThis group will not receive the medrol dosepak. They will still complete the daily survey until they return for their postoperative appointment, one week after their surgery.

What is being measured

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

  1. Postoperative pain level

    Pain measured on a 5 point likert scale from no pain at all to worst pain ever experienced

    Measured: Daily for 7 days

  2. Nausea

    Nausea measured on 5 point likert scale from no pain at all to worst pain ever experienced

    Measured: Daily for 7 days

  3. Edema

    Edema measured based on a reference image. Edema rated based on how far from nose and eyes has any swelling dispersed.

    Measured: Daily for 7 days

  4. Bruising

    Bruising measured based on a reference image. Bruising rated based on how far from the nose and eyes did bruising extend to.

    Measured: Daily for 7 days

Timeline

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

  1. First posted3 Jul 2024
  2. Study startJan 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Why it stopped: Study was never started

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06483204
Sponsor's protocol ID
#240474
Status last verified
Nov 2025
First submitted
25 Jun 2024
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no current plan to share individual patient data with other researchers.

Publications

  • da Silva EM, Hochman B, Ferreira LM. Perioperative corticosteroids for preventing complications following facial plastic surgery. Cochrane Database Syst Rev. 2014 Jun 2;2014(6):CD009697. doi: 10.1002/14651858.CD009697.pub2.

    PubMed 24887069
  • Hwang SH, Lee JH, Kim BG, Kim SW, Kang JM. The efficacy of steroids for edema and ecchymosis after rhinoplasty: a meta-analysis. Laryngoscope. 2015 Jan;125(1):92-8. doi: 10.1002/lary.24883. Epub 2014 Aug 18.

    PubMed 25131000
  • Wu TJ, Huang YL, Kang YN, Chiu WK, Chen JH, Chen C. Comparing the efficacy of different steroids for rhinoplasty: A systematic review and network meta-analysis of randomized controlled trials. J Plast Reconstr Aesthet Surg. 2023 Sep;84:121-131. doi: 10.1016/j.bjps.2023.04.087. Epub 2023 May 3.

    PubMed 37329745

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Medrol 4 MG Oral Tablet Includes Medrol Dosepak in people with Edema and Bruising, run by Vanderbilt University Medical Center.

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 2 inclusion and 10 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: withdrawn, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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 level (time frame: Daily for 7 days). 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 NCT06483204, which also lists 3 linked publications.

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 18 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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