Clinical trial NCT03190642: Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery
Official title: Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Edema
Steroid Use
Keywords: Orthognathic Surgery
Swelling
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2017-06-19
Enrollment: 180
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative edema
timeFrame: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, whichever comes first
Secondary outcomes:
measure: Patient perceived swelling
timeFrame: Post-operative day 2
measure: Post-operative pain
timeFrame: Post-operative day 2
measure: Post-operative sleep
timeFrame: Post-operative day 2
measure: Post-operative nausea
timeFrame: Post-operative day 2
measure: Length of hospital stay
timeFrame: Until discharge from hospital or post-operative day 100, which ever comes first
measure: Rate of post-operative infection
timeFrame: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, which ever comes first
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QE II Health Sciences Center
state: Nova Scotia
Study officials:
References:
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