Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 11:54 PM
Study NCT ID:
NCT06483204
Status:
WITHDRAWN
Last Update Posted:
2025-11-18
First Post:
2024-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroids for Rhinoplasty: Pain, Nausea, Edema and Ecchymosis
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Steroids for Rhinoplasty: Pain, Nausea, Edema and Ecchymosis
Status:
WITHDRAWN
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: