A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery
I. To prospectively determine if a longer 4-day course of dexamethasone (or equivalent) for
the management of postoperative pain and dysphagia following transoral robotic surgery
(TORS) is superior to the current standard of a single injection of dexamethasone 10 mg.
I. Determine the effect of postoperative corticosteroids on postoperative dysphagia
II. Determine the effect of postoperative corticosteroids on length of hospital stay
III. Determine the complications associated with postoperative corticosteroid use after
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive dexamethasone intravenously (IV) at the time of surgery and orally
(PO) every 8 hours for up to 4 days following surgery.
ARM II: Patients receive dexamethasone IV at the time of surgery and placebo PO every 8
hours for up to 4 days following surgery.
After completion of study treatment, patients are followed up for up to 21 days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Pain visual analogue scale (VAS) score measured at 10-point scale
It will be measured at five time points (baseline, days 1, 2, 3 and 7-21 days after surgery). A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups.
Up to 21 days
Oregon Health and Science University
United States: Food and Drug Administration
|OHSU Knight Cancer Institute||Portland, Oregon 97239|