Pain after thoracoscopic surgery MedDRA version: 14.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Solu-Medrol
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: Methylprednisolonsuccinat
Other descriptive name: METHYLPREDNISOLONE SODIU
Sponsors
Per F. Jensen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 yars. Scheduled for Video-assisted thoracoscopic lobectomy. Signed informed consent. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Cant co-operate to take part in the study. Do not speak or understand danish. Not scheduled for follow-up in the Rigshospitalet. Allegies to any medicine used in the study. Symptomatic gastric ulcur. cardiac insufficiency (NYHA > 2). Reduced kidney function. Medical treated diabetes mellitus. Abuse of medicine and/or alcohol. Daily use of psycoactive drugs. Neurological disease that could influence the perception of pain. Breats feeding ore expecting mothers. Previously had thoragic surgery on the same side. Daily use of steroids in the period from three months before the operation til two days after the operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show a supplemental analgesic effect of methylprednisolone on acute postoperative pain after video-assisted thoracig surgery;Secondary Objective: Not applicable;Primary end point(s): Area under curve for pain scores at rest and after defined movements (numeric rating scale) 0 - 48 hours postoperative.;Timepoint(s) of evaluation of this end point: continuously until 48 hours postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of nausea and vomiting. Use of analgetics and anti-emetics. Localisation of pain. The position of the chest tube. Volume of drainage on the day of operation. Incidence of delayed wound healing. Incidence of infections in the postoperativ period. Fatigue. Sleep quality. Blood glucose on the day of operation.;Timepoint(s) of evaluation of this end point: Incidence of nausea and vomiting, use of analgetics and anti-emetics, localisation of pain, fatigue and sleep quality is followed until 48 hours postoperative. Blood glucose is measured in intervals of three hours during the day of operation. The position of the chest tube is registered at the end of the operation. Volume of drainage is assecced in the morning at the first postoperative day. Incidence of delayed wound healing and infektions is followed in 12 weeks after the operation. | — |
Countries
Denmark
Contacts
Public ContactLars Bjerregaard
Rigshospitalet
Outcome results
None listed