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.
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.
- Conditions
- Edema, Bruising, Nasal Obstruction, Postoperative Pain, Postoperative Nausea, Postoperative Complications
- 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 group | Role | What they receive |
|---|---|---|
| Medrol dosepak group | Experimental | For 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 group | No intervention | This 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.
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
Nausea
Nausea measured on 5 point likert scale from no pain at all to worst pain ever experienced
Measured: Daily for 7 days
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
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.
- First posted3 Jul 2024
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: Study was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EdemaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priyesh Patel, Vanderbilt University Medical Center
- Investigators
- Priyesh N Patel, MD, Principal investigator, Vanderbilt University Medical Center
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 24887069Hwang 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 25131000Wu 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroids for Rhinoplasty: Pain, Nausea, Edema and Ecchymosis
- ClinicalTrials.gov ID
- NCT06483204
- Acronym / sponsor ID
- #240474
- Conditions
- Edema, Bruising, Nasal Obstruction, Postoperative Pain, Postoperative Nausea, Postoperative Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Jul 2024 (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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medrol dosepak group | Experimental | Drug: Medrol 4 MG Oral Tablet Includes Medrol DosepakFor 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. |
| No medrol dosepak group | No intervention | –This 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- revision rhinoplasty
- diabetic patients
- patients with an allergy to steroids
- use of PPE implants
- parents receiving concurrent sinus surgery
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 |
|---|---|---|
| Medrol 4 MG Oral Tablet Includes Medrol DosepakAlso: methylprednisoloneMedrol 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. | Drug | Medrol dosepak group |
Primary outcome
Postoperative pain level
Time frame: Daily for 7 days
Pain measured on a 5 point likert scale from no pain at all to worst pain ever experienced
Nausea
Time frame: Daily for 7 days
Nausea measured on 5 point likert scale from no pain at all to worst pain ever experienced
Edema
Time frame: Daily for 7 days
Edema measured based on a reference image. Edema rated based on how far from nose and eyes has any swelling dispersed.
Bruising
Time frame: Daily for 7 days
Bruising measured based on a reference image. Bruising rated based on how far from the nose and eyes did bruising extend to.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 24887069da 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.
- Background: PubMed 25131000Hwang 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.
- Background: PubMed 37329745Wu 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.
- Individual participant dataSharing planned: No. There is no current plan to share individual patient data with other researchers.
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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.
Priyesh N Patel, MD principal investigator
Vanderbilt University Medical Center
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.