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

University of Trieste

Status: Completed

Conditions: Postoperative Pain; Dexamethasone Adverse Reaction; Analgesia; Postoperative Thoracic Procedure Complication

Treatments: Drug: Dexamethasone

Study type: Observational

Funder types: Other

Identifiers

NCT04325984

173_2018_DexaPOP

Details and patient eligibility

About

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).

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

62 participants in 2 patient groups

Dexamethasone group

Description:

Group of patients receiving dexamethasone 8 mg as part of the multimodal analgesia.

Treatment:

Drug: Dexamethasone

Control group

Description:

Group of patients receiving multimodal analgesia, not comprising dexamethasone; moreover, ondansetron 4 mg is administered for the control of PONV.