Postoperative pain following transoral robotic surgery
Conditions
Interventions
Trade Name: Dexa-Ratiopharm
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dexamethasone
CAS Number: 312-93-6
Other descriptive name: DEXAMETHASONE PHOSPHATE
Concentration unit: mg m
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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 o TORS 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Length of hospitalization • Use of PRN pain medication • Postoperative bleeding (Any postoperative bleeding during the primary hospitalization) • Postoperative infection (Any postoperative infection during the primary hospitalization - Pneumonia must be verified by radiological examination) • Hyperglycemia (A preoperatively blood sugar sample will be performed. Blood sugar measurements will be obtained again at day 2 and 4) • Postoperative nausea and vomiting (Self-assessed and noted in the patient’s pain dairy) • Number of reoperations • Number of tracheotomy procedures (Peroperatively and postoperative during the first 30 days) • Unplanned readmission (Unplanned readmission to an department of otorhinolaryngology during the first 30 postoperative days ) • Time to feeding tube removal if placed (Measured in days from tube placement until removal stated by a medical doctor - Additional feeding tube placement during the first 30 days will be noted in the patient CRF and are collected from the electronic journal ) • Self-assessed food intake consistency during the first 14 days • Weight difference (Between admission weight and discharge weight) ;Timepoint(s) of evaluation of this end point: During hospitalization and until 14 days postoperatively | — |
Countries
Denmark
Contacts
Public ContactMikkel Larsen
Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
Outcome results
None listed