Steroids for Rhinoplasty: Pain, Nausea, Edema and Ecchymosis

NCT06483204 | Withdrawn Phase 4 DMC

• 1 other identifier: #240474
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Postoperative pain level

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

  Daily for 7 days

• Nausea

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

  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.

  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.

  Daily for 7 days

Study Arms (2)

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.

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.

Interventions

Medrol 4 MG Oral Tablet Includes Medrol Dosepak 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.

Also known as: methylprednisolone

Medrol dosepak group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Related Publications (3)

• 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.

  PMID: 24887069 BACKGROUND

• 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.

  PMID: 25131000 BACKGROUND

• 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.

  PMID: 37329745 BACKGROUND

MeSH Terms

Conditions

Edema; Contusions; Nasal Obstruction; Pain, Postoperative; Postoperative Nausea and Vomiting; Postoperative Complications

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds, Nonpenetrating; Wounds and Injuries; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Pathologic Processes; Pain; Neurologic Manifestations; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Priyesh N Patel, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Priyesh N. Patel

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 3, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share