A Randomized, Double-blind, Placebo-controlled Trial Of Extended Course Corticosteroid For Post-operative Pain Control Following Transoral Robotic Surgery (tors)

Presentation: S062
Topic: Oropharynx
Type: Oral
Date: Sunday, July 17, 2016
Session: 1:45 PM - 3:15 PM Robotics II
Authors: Daniel Clayburgh, MD, PhD1, Will Stott, BS1, Rachel Bolognone, MS, CCCSLP1, Andrew Palmer, PhD, CCCSLP1, Virginie Achim, MD1, Scott Troob, MD1, Ryan Li, MD1, Daniel Brickman, MD1, Donna Graville, PhD, CCCSLP1, Peter Andersen, MD1, Neil Gross, MD2
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Institution(s): 1Oregon Health and Science University, 2MD Anderson Cancer Center
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Introduction: The introduction of transoral robotic surgery (TORS) has facilitated a less invasive method for resection of oropharyngeal squamous cell carcinoma (OPSCC).  Perioperative management of patients after TORS can be challenging, particularly with respect to pain control.  Poorly controlled postoperative pain can significantly limit oral intake, necessitating the use of tube feeding and increasing hospital length of stay.  Corticosteroids have been shown to reduce pain following simple tonsillectomy.  In this study, we hypothesized that an extended course of corticosteroids may improve pain control following TORS.

Methods: Patients undergoing TORS for OPSCC were enrolled into the study and randomized to one of two treatment arms.  All subjects received a 10mg intraoperative dose of dexamethasone.  Subjects were then randomized to receive 8mg dexamethasone three times daily (Arm 1) or placebo (Arm 2) until discharge up to a maximum of 4 days after surgery.  Both subjects and the treatment team were blinded to study treatment.  All patients had a nasogastric feeding tube placed at the time of surgery and maintained until adequate oral intake was demonstrated.  The primary outcome measure was pain, assessed on a 10-point visual analog scale (VAS) on postoperative day (POD) 1, 2, 3, and 7-14 day follow-up.  Secondary outcome measures included time to initiation of oral intake, length of feeding tube use, length of hospital stay, dysphagia (EAT-10 questionnaire), quality-of-life (QOL) (University of Michigan questionnaire) and complications.  A priori power analysis estimated a need for 36 patients in each treatment arm.

Results: 72 total subjects are needed for completion of this study; at the time of abstract submission (January 2016), 68 subjects have been enrolled and completed study treatment.  Study completion is anticipated in March-April of 2016.  Unblinding of the treatment regimen will not occur until all patients have completed the treatment protocol.  All patients enrolled have had tumor (T) classification 1 or 2.  Forty-five subjects underwent partial pharyngectomy/radical tonsillectomy, and 34 underwent base of tongue resection (12 patients had both procedures performed).  VAS pain score on POD1 was 4.7±2.4, on POD2 4.4± 2.3, on POD3 4.3±2.3, and at 1-2 week follow up, 2.7±2.0 for the entire cohort.  Preoperative EAT-10 score was 4.5±6.9, and at 1-2 week follow up 19.6±9.4 (p<0.001).  All domains of the UMQOL survey showed statistically significant decreases at 1-2 weeks postoperatively compared to preoperative assessment.  Patients required a nasogastric feeding tube for a median of 6.5 days postoperatively, lost a mean of 9.5±6.7 pounds in the 2 weeks after surgery, and were hospitalized for a mean of 4.7±1.8 days. 

Conclusions: TORS for OPSCC has a significant short-term impact on patient comfort, swallowing, and quality of life.  Interventions to improve pain control after TORS are needed to allow for a faster return to normal diet, earlier removal of feeding tubes, and decreased hospital length of stay.  The results of this study, which will be completed well before the 9th International Congress on Head and Neck Cancer, will determine if extended-course corticosteroid treatment improves pain control and short-term outcomes following TORS for OPSCC.

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