An investigation of postoperative pain, why still in hospital and days alive and out of hospital following transoral robotic surgery for squamous cell carcinoma of unknown primary and obstructive sleep apnea

Phase 1

• Conditions: Postoperative pain following transoral robotic surgery; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2019-004610-34-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-11
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

•18 years or older
•Ability to provide a written informed consent
•ECOG/WHO performance status 0-2
•Squamous cell carcinoma of unknown primary or obstructive sleep apnea
•Booked for TORS based on radiologic and clinical assessment by the surgeon
oTORS for obstructive sleep apnea must be preceded by a Drug-induced sleep endoscopy (DISE) examination
•Negative Urine HCG pregnancy test for women in the fertile age.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Serious medical comorbidities (ECOG/WHO performance status >2). Other contraindications to surgery
•Distant metastasis
•Active Herpes zoster
•Previous head and neck cancer
•Significant trismus, maximum inter-incisal opening ? 35mm
•Insulin dependent diabetes
•Allergy to glucocorticoids
•Preoperative use of systemic glucocorticoids <90 days before the surgery
•Preoperative use of biological anti-inflammatory medication <90 days before the surgery
•Suspected active gastric ulcer by in the opinion of the investigator
•Pregnancy/Breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of high dose steroids on the postoperative pain level measured by self-assessed VAS during rest and swallowing following transoral robotic surgery;Secondary Objective: Length of stay, surgical complications, use of PRN pain medications, postoperative nausea and vomitting, unplanned readmissions, food intake consistensy, weight difference between admission and discharge, HPV status, location of a found primary tumor ;Primary end point(s): Self assessed Pain intensity on a visual analoge scale (VAS);Timepoint(s) of evaluation of this end point: During hospitalization and until 14 days after the procedure