Skip to main content
OpenTrials
Completed

NCT Number: NCT04325984

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dexamethasone Adverse Reaction Agnosia Analgesia Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nausea Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Postoperative Thoracic Procedure Complication Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cattinara Hospital

Trieste, 34149, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

To the Dexamethasone group, at the moment of the induction of anaesthesia, dexamethasone 8 mg is administered.

Primary outcomes

  1. Morphine consumption

    Time frame: 24 hours after surgery

    Morphine dose, in milligrams, administered in the 24 hours after the surgery

Secondary outcomes

  1. Static and dynamic Numeric Rating Scale (NRS)

    Time frame: 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 outcomes

  1. Glycemic changes

    Time frame: 24 hours after surgery

    Evaluation of intraoperative and postoperative blood glucose levels

  2. Surgical wound infection

    Time frame: 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

  3. Postoperative Nausea and Vomiting (PONV)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2020
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.