Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery

August 2, 2021 updated by: Jean Charles Doucet

The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use of one gram of methylprednisolone administered intravenously prior to orthognathic surgery. This is largely based on the work of Habal. The administration of one gram of methylprednisolone can be concerning for the anesthesiologist since this is an unusually large dose of steroid in comparison to use in other surgical specialties. As with most medications, the chances of steroid-related complications increase with increasing doses of steroids.

The researchers are proposing a prospective, double-blind randomized control trial to determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively instead of one gram of methylprednisolone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Orthognathic surgery is a commonly performed surgery to correct facial functional and esthetic deformities. At the Atlantic Centre of Oral and Maxillofacial Surgery in Halifax, Nova Scotia, over 300 of these surgeries are carried out yearly. Orthognathic surgery is comprised of procedures performed in both the maxilla and mandible which include Lefort 1, bilateral sagittal split and functional (BSSO) and functional genioplasty. Common sequelae after orthognathic surgery include post-operative pain and swelling.

Swelling occurs almost universally to some degree after orthognathic surgery. Steroid therapy has long been advocated for the reduction of post-operative swelling in oro-facial surgeries, as there is good evidence to support its use for this purpose. In 1978, Habal showed that one gram of methylprednisolone administered in a controlled dog model reduced post-operative swelling. He later carried this over to his practice of cosmetic facial surgeries. His studies have laid the much of the ground work for the use of steroid therapy in head and neck surgeries today.

Other studied benefits of steroid use in facial surgery include decreased post-operative pain, trismus, nausea and vomiting as well as decreased length of hospital stays. Complications of steroid use include compromised healing or infection, sleep disturbances, hyperglycemia, avascular necrosis of bone, steroid-related acne and adverse psychiatric effects.

The use of perioperative steroids as a means of swelling control is the current standard of care in the practice of orthognathic surgery. Despite this fact, there is little consensus on the ideal steroid regimen (i.e. type and dosing) to use for surgery. As such, the use of steroids in Oral and Maxillofacial surgical practices are based primarily on surgeon's preference and familiarity with a particular steroid regimen. This is likely due to the weak evidence in published literature in favor of a steroid regimen to mitigate post-operative swelling.

Most literature in favor of particular steroid regimens involves crude or arbitrary measurements of swelling. In 1978, Habal showed that one gram of methylprednisolone administered in a controlled dog model reduced post-operative swelling. This observation was made by a trained observer against a control group who received no steroid. Other studies have had trained observers look at post-operative photographs of patients who had undergone orthognathic surgery to stratify which had "more" or "less" swelling. Another study attempted to quantify the degree of post-operative swelling by measuring the distance between the earlobes under the chin. These authors acknowledged that this could be altered by the facial movements produced during orthognathic surgery and that better means of measurement of facial swelling should be employed in future research.

The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use of one gram of methylprednisolone administered intravenously prior to orthognathic surgery. This is largely based on the work of Habal. The administration of one gram of methylprednisolone can be concerning for the anesthesiologist since this is an unusually large dose of steroid in comparison to use in other surgical specialties. As with most medications, the chances of steroid-related complications increase with increasing doses of steroids.

The researchers are proposing a prospective, double-blind randomized control trial to determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively instead of one gram of methylprednisolone, which is the current standard of care in our department. One hundred and twenty-five milligrams of methylprednisolone is a readily available dose of steroids and has been shown in several studies to be effective in the reduction of swelling after oral surgeries and other swelling-related conditions. In their systematic literature review of corticosteroid administration in oral and orthognathic surgery, Dan et al. concluded that a preoperative dose of methylprednisolone >85mg results in a significant decrease in post-operative oedema. The researchers hypothesize that there will be little difference between groups with regards to primary study outcome measure of post-operative swelling.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QE II Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients age 14 and over undergoing orthognathic surgery at the Atlantic Centre of Oral and Maxillofacial Surgery in Halifax, Nova Scotia will be included in our study. The clinic is located in the Victoria General Hospital in Halifax, Nova Scotia. Orthognathic surgery includes any combination of Lefort 1, Bilateral Sagittal Split Osteotomy (BSSO) and functional genioplasty procedures.

Exclusion Criteria:

  • Patients with pertinent medical history that precludes the use of high-dose steroids will be excluded from our study. This includes:

    • Known hypersensitivity to steroids
    • Type 1 diabetic patients who may have a severe elevation of blood sugars with steroid use.
    • Systemic fungal infections
    • Arrested tuberculosis
    • Herpes simplex keratitis
    • Acute psychoses
    • Cushing's syndrome
    • Peptic ulcer disease
    • Pregnant patients and patients with current infections will be excluded Breast feeding mother

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1000mg methylprednisolone group
Evaluating effects of 1000mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling.
Drug: Methylprednisolone
Administration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery.
Other Names:
  • Solumedrol
Active Comparator: 125mg methylprednisolone group
Evaluating effects of 125mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling.
Drug: Methylprednisolone
Administration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery.
Other Names:
  • Solumedrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative edema
Time Frame: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, whichever comes first
Measurement of post-operative edema using 3D facial scanner
Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient perceived swelling
Time Frame: Post-operative day 2
Measurement of post-operative patient perceived swelling via survey
Post-operative day 2
Post-operative pain
Time Frame: Post-operative day 2
Measurement of post-operative pain via survey
Post-operative day 2
Post-operative sleep
Time Frame: Post-operative day 2
Measurement of post-operative sleep via survey
Post-operative day 2
Post-operative nausea
Time Frame: Post-operative day 2
Measurement of post-operative nausea via survey
Post-operative day 2
Length of hospital stay
Time Frame: Until discharge from hospital or post-operative day 100, which ever comes first
Measurement of length of post-operative hospital stay
Until discharge from hospital or post-operative day 100, which ever comes first
Rate of post-operative infection
Time Frame: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, which ever comes first
Measurement of post-operative infections
Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, which ever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jean Charles Doucet

Collaborators

Nova Scotia Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

June 11, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMFSTEROIDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

NO IPD will be shared with researchers outside of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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