Role of Dexamethasone in Multimodal Analgesia for Postoperative Pain in Thoracic Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ruolo Del Desametasone Per il Controllo Multimodale Del Dolore Postoperatorio in Chirurgia Toracica

Conditions
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Dexamethasone Adverse Reaction, Postoperative Pain, Postoperative Thoracic Procedure Complication, Analgesia

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexamethasone group<br>Group of patients receiving dexamethasone 8 mg as part of the multimodal analgesia. | Drug: Dexamethasone<br>* To the Dexamethasone group, at the moment of the induction of anaesthesia, dexamethasone 8 mg is administered.<br>|
| Control group<br>Group of patients receiving multimodal analgesia, not comprising dexamethasone; moreover, ondansetron 4 mg is administered for the control of PONV. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Morphine dose, in milligrams, administered in the 24 hours after the surgery | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static and dynamic Numeric Rating Scale (NRS) | Evaluation of Numeric Rating Scale (NRS) for static and dynamic pain; the NRS uses scores from 0 (no pain) to 10 (worst possible pain) | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic surgery, Postoperative complications, Dexamethasone, Postoperative Nausea and Vomiting, Hyperglycaemia, Video Assisted ThoracoScopy (VATS), Multimodal Analgesia