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

Post-operative Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190642
• Other study ID #: OMFSTEROIDS
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2021
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Post-operative Edema
• Steroid Use

Intervention

Drug:
• Methylprednisolone
Administration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery.

Locations

Country	Name	City	State
Canada	QE II Health Sciences Center	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Jean Charles Doucet	Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (15)

Chegini S, Dhariwal DK. Review of evidence for the use of steroids in orthognathic surgery. Br J Oral Maxillofac Surg. 2012 Mar;50(2):97-101. doi: 10.1016/j.bjoms.2010.11.019. Epub 2011 Feb 12. Review. — View Citation

Dan AE, Thygesen TH, Pinholt EM. Corticosteroid administration in oral and orthognathic surgery: a systematic review of the literature and meta-analysis. J Oral Maxillofac Surg. 2010 Sep;68(9):2207-20. doi: 10.1016/j.joms.2010.04.019. Epub 2010 Jun 29. Review. — View Citation

Esen E, Tasar F, Akhan O. Determination of the anti-inflammatory effects of methylprednisolone on the sequelae of third molar surgery. J Oral Maxillofac Surg. 1999 Oct;57(10):1201-6; discussion 1206-8. — View Citation

Galen DM, Beck M, Buchbinder D. Steroid psychosis after orthognathic surgery: a case report. J Oral Maxillofac Surg. 1997 Mar;55(3):294-7. — View Citation

Guernsey LH, DeChamplain RW. Sequelae and complications of the intraoral sagittal osteotomy in the mandibular rami. Oral Surg Oral Med Oral Pathol. 1971 Aug;32(2):176-92. — View Citation

Habal MB, Powell RD. Experimental facial edema: treatment with methylprednisolone. J Surg Res. 1978 May;24(5):353-8. — View Citation

Habal MB. Prevention of postoperative facial edema with steroids after facial surgery. Aesthetic Plast Surg. 1985;9(2):69-71. — View Citation

Huamán ET, Juvet LM, Nastri A, Denman WT, Kaban LB, Dodson TB. Changing patterns of hospital length of stay after orthognathic surgery. J Oral Maxillofac Surg. 2008 Mar;66(3):492-7. doi: 10.1016/j.joms.2007.08.025. — View Citation

Ichinose M, Sugiura H, Nagase H, Yamaguchi M, Inoue H, Sagara H, Tamaoki J, Tohda Y, Munakata M, Yamauchi K, Ohta K; Japanese Society of Allergology. Japanese guidelines for adult asthma 2017. Allergol Int. 2017 Apr;66(2):163-189. doi: 10.1016/j.alit.2016.12.005. Epub 2017 Feb 11. Review. — View Citation

Lübbers HT, Medinger L, Kruse A, Grätz KW, Matthews F. Precision and accuracy of the 3dMD photogrammetric system in craniomaxillofacial application. J Craniofac Surg. 2010 May;21(3):763-7. doi: 10.1097/SCS.0b013e3181d841f7. — View Citation

Poetker DM, Reh DD. A comprehensive review of the adverse effects of systemic corticosteroids. Otolaryngol Clin North Am. 2010 Aug;43(4):753-68. doi: 10.1016/j.otc.2010.04.003. Review. — View Citation

Precious DS, Hoffman CD, Miller R. Steroid acne after orthognathic surgery. Oral Surg Oral Med Oral Pathol. 1992 Sep;74(3):279-81. — View Citation

van der Meer WJ, Dijkstra PU, Visser A, Vissink A, Ren Y. Reliability and validity of measurements of facial swelling with a stereophotogrammetry optical three-dimensional scanner. Br J Oral Maxillofac Surg. 2014 Dec;52(10):922-7. doi: 10.1016/j.bjoms.2014.08.019. Epub 2014 Sep 15. — View Citation

Weber CR, Griffin JM. Evaluation of dexamethasone for reducing postoperative edema and inflammatory response after orthognathic surgery. J Oral Maxillofac Surg. 1994 Jan;52(1):35-9. — View Citation

Widar F, Kashani H, Alsén B, Dahlin C, Rasmusson L. The effects of steroids in preventing facial oedema, pain, and neurosensory disturbances after bilateral sagittal split osteotomy: a randomized controlled trial. Int J Oral Maxillofac Surg. 2015 Feb;44(2):252-8. doi: 10.1016/j.ijom.2014.08.002. Epub 2014 Oct 7. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative edema	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	Patient perceived swelling	Measurement of post-operative patient perceived swelling via survey	Post-operative day 2
Secondary	Post-operative pain	Measurement of post-operative pain via survey	Post-operative day 2
Secondary	Post-operative sleep	Measurement of post-operative sleep via survey	Post-operative day 2
Secondary	Post-operative nausea	Measurement of post-operative nausea via survey	Post-operative day 2
Secondary	Length of hospital stay	Measurement of length of post-operative hospital stay	Until discharge from hospital or post-operative day 100, which ever comes first
Secondary	Rate of post-operative infection	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