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

Completed

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

• Registration Number: NCT04325984
• Lead Sponsor: University of Trieste

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.

Study Timeline

• Study Start: 2017-08-29
• Primary Completion: 2019-03-06
• Study Completion: 2019-03-06
• Status Verified: 2020-03
• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dexamethasone group	Dexamethasone	Group of patients receiving dexamethasone 8 mg as part of the multimodal analgesia.

Primary Outcome Measures

Name	Time	Method
Morphine consumption	24 hours after surgery	Morphine dose, in milligrams, administered in the 24 hours after the surgery

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Cattinara Hospital; 🇮🇹 Trieste, Italy