Dexamethasone disodium phosphate for Lung cancer

Inclusion criteria

• {"criterion_text":"- Age >18 years\n- Able to understand written and spoken Danish language\n- Pain Catastrophizing Scale ≥ 20\n- Patient planned to elective Video-Assisted Thoracoscopic Surgery Lobectomy/Segmentectomy"}

Exclusion criteria

• {"criterion_text":"- Patients undergoing systemic glucocorticoid or other immunosuppressive therapies, excluding inhaled steroids.\n- Individuals undergoing conversion to a surgical procedure other than VATS lobectomy/segmentectomy.\n- Individuals with diabetes requiring insulin treatment.\n- Pregnant or breastfeeding patients.\n- Patients with known allergies to the study drug.\n- Individuals with mental disabilities that may impair their capacity to provide informed consent or compromise the validity of data collection.\n- Patients with diagnosed schizophrenia, active psychosis, bipolar disorder, or a history of ongoing treatment with antipsychotic and/or antidepressant medications\n- Individuals with altered pain perception due to other conditions or injuries, such as spinal cord or brain injuries, severe polyneuropathies, or neurological disorders\n- Regular users of opioid medications.\n- Patients requiring reoperation within the first two postoperative days"}

Primary endpoints

• {"endpoint_text":"- Pain when coughing on the morning on POD1 (Numeric Rating Scale 0-10)","definition_or_measurement_approach":"Measured using a Numeric Rating Scale (NRS) 0-10 when coughing on the morning of postoperative day 1 (POD1)."}

Secondary endpoints

• {"endpoint_text":"- Pain at 5-meter walk test in the morning and afternoon POD1+2 (NRS)\n- Pain when coughing on the afternoon POD1 + morning and afternoon POD2 (NRS)\n- Postoperative length of stay (in days)\n- Cumulative use of rescue analgesics per day during POD1+2\n- Cumulative use of rescue antiemetics per day during POD1+2\n- Reasons for re-admission within 30 days (defined as overnight hospital stay after discharge)\n- Intensive Care Unit Days\n- Pain Catastrophizing Scale (PCS)\n- Morbidity and mortality (30-day)\n- Quality of recovery questionnaire (QoR15) in day 7\n- Nausea (NRS)\n- Episodes of vomiting","definition_or_measurement_approach":"Pain measures use NRS where specified (0-10). Postoperative length of stay measured in days. Cumulative use of rescue medications measured per day during POD1+2. Reasons for readmission defined as overnight hospital stay within 30 days. ICU days counted. PCS and QoR15 are validated questionnaires at specified timepoints. Morbidity/mortality assessed at 30 days. Nausea by NRS; vomiting by episode counts."}

Denmark

Earliest CTIS Part Ii Submission Date

22-04-2025

Latest Decision Or Authorization Date

28-04-2025

Processing Time Days

6

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}