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Postoperative Pain, Why Still in Hospital and DAOH Following TORS for SCCUP & OSAS

NCT04189107 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-03-16

No results posted yet for this study

Summary

This protocol investigates the effect of a high dose dexamethasone regimen in the treatment of postoperative pain following Transoral Robotic Surgery (TORS). The protocol consists of three substudies.

1. Randomized double-blinded clinical trial assigning half of the participants to a high-dose dexamethasone regimen while the other half will receive a low-dose dexamethasone dosage and placebo in the first postoperative period.
2. A investigation of "Why in hospital?" following TORS. From the first postoperative day until discharge reasons for continued hospitalization will be registered in order to identify clinical and organizational factors contributing to hospitalization
3. An assessment of "Days Alive and Out of Hospital" following TORS. From the day of surgery and the first 12 postoperative months all admissions to a hospital ward will be registered along with admission reasons. Any death during the first 12 months will be noted with a cause of death.

Conditions

  • Analgesia
  • Surgery
  • Cancer of Head and Neck
  • Oropharyngeal Cancer
  • Carcinoma of Unknown Primary
  • Pain, Postoperative
  • Postoperative Pain

Interventions

DRUG

Dexamethasone

High-dose dexamethasone peroperative and postoperative on day 2 and 4

DRUG

Placebo

low dose dexamethasone peroperative and placebo postoperatively on day 2 and 4

Sponsors & Collaborators

  • Candys Foundation

    collaborator UNKNOWN

  • Region Capital Denmark

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2022-11-09
Completion
2022-11-09

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04189107 on ClinicalTrials.gov