Analgesia, Dexamethasone Adverse Reaction, Postoperative Pain, Postoperative Thoracic Procedure Complication
Conditions
Keywords
Thoracic surgery, Postoperative complications, Dexamethasone, Postoperative Nausea and Vomiting, Hyperglycaemia, Video Assisted ThoracoScopy (VATS), Multimodal Analgesia
Brief summary
The aim of the study is to evaluate the analgesic properties of dexamethasone and to quantify the possible associated postoperative complications, such as wound infections and hyperglycaemia, in patients who underwent lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or video-assisted thoracoscopic surgery (VATS).
Detailed description
We designed an observational study, aimed to evaluate the possible reduction in morphine consumption in thoracic patients, who were administered dexamethasone compared to who didn't received the drug. The research wants to assess the presence of additional analgesic properties, besides the well known antiemetic effect, in the intraoperative administration of dexamethasone, and the possible postoperative complications, such as wound infections and hyperglycaemia. The rational is to ameliorate the anaesthesiological management, in particular with a view to a opioid-sparing analgesia in thoracic patients. To do so, we enrolled thoracic patients, who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or video-assisted thoracoscopic surgery (VATS). We selected two groups: one in which patients were administered dexamethasone 8 mg at the moment of induction, and the other one in which patients didn't received dexamethasone, but ondansetron 4 mg at the end of surgery. Both groups received other antiemetic drugs based on Apfel score and multimodal analgesia, comprising loco-regional analgesia, opioids and other analgesic drugs administration. The we checked morphine consumption and Numerical Rating Scale (NRS) values for pain in the first 24 hours after surgery. Moreover we evaluate Post-Operative Nausea and Vomiting (PONV), intra- and post-operative blood glucose levels and wound infection.
Interventions
To the Dexamethasone group, at the moment of the induction of anaesthesia, dexamethasone 8 mg is administered.
Sponsors
Study design
Eligibility
Inclusion criteria
* BMI \< 30 kg/m2 * ASA I-III * Lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS
Exclusion criteria
* Refusal by the patient to participate or patient unable to express his own consent * Chronic therapy with medium-high doses of corticosteroids * Chronic therapy with opioids * METS ≤ 4, defining an overall decreased cardiovascular fitness * Urgent or emergency surgery * Allergy to the active ingredient of the drug used * Kidney failure at stage III or more * Liver failure * Pregnancy * Drug addiction, patients with a history of drug abuse * Corrected Qt interval (QTc) \> 0,45 for males and 0,47 for women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption | 24 hours after surgery | Morphine dose, in milligrams, administered in the 24 hours after the surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Static and dynamic Numeric Rating Scale (NRS) | 24 hours after surgery | Evaluation of Numeric Rating Scale (NRS) for static and dynamic pain; the NRS uses scores from 0 (no pain) to 10 (worst possible pain) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glycemic changes | 24 hours after surgery | Evaluation of intraoperative and postoperative blood glucose levels |
| Surgical wound infection | At hospital discharge/ at first medical check if discharge was earlier than 7 days | Evaluation of infectious complication after surgery: assessment of the presence of signs and symptoms of infection of the surgical wound |
| Postoperative Nausea and Vomiting (PONV) | 24 hours after surgery | Evaluation of development of postoperative nausea or vomiting, reporting the presence of episodes of nausea or vomiting in the 24 hours after the surgery |
Countries
Italy