Steroids for Rhinoplasty: Pain, Nausea, Edema and Ecchymosis

NCT ID: NCT06483204

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

Brief 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. 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.

Conditions

Edema; Bruising; Nasal Obstruction; Postoperative Pain; Postoperative Nausea; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Medrol dosepak group

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.

Group Type: EXPERIMENTAL

Medrol 4 MG Oral Tablet Includes Medrol Dosepak

Intervention Type: DRUG

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.

No medrol dosepak group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Medrol 4 MG Oral Tablet Includes Medrol Dosepak

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.

Intervention Type: DRUG

Other Intervention Names

methylprednisolone

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Patients that are pregnant or attempting to conceive
• Liver failure or cirrhosis
• Diagnosis of hypothyroidism
• Diagnosis of glaucoma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Priyesh Patel

Dr. Priyesh N. Patel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Priyesh N Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

References

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.

Reference Type: BACKGROUND

PMID: 24887069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25131000 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37329745 (View on PubMed)

Other Identifiers

#240474

Identifier Type: -

Identifier Source: org_study_id