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

March 27, 2020 updated by: Marzia Umari, University of Trieste

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Trieste, Italy, 34149
        • Cattinara Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted at our surgical center who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dexamethasone group
Group of patients receiving dexamethasone 8 mg as part of the multimodal analgesia.
Drug: Dexamethasone
To the Dexamethasone group, at the moment of the induction of anaesthesia, dexamethasone 8 mg is administered.
Control group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 24 hours after surgery
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)
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)
24 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic changes
Time Frame: 24 hours after surgery
Evaluation of intraoperative and postoperative blood glucose levels
24 hours after surgery
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
At hospital discharge/ at first medical check if discharge was earlier than 7 days
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
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Trieste

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 29, 2017

Primary Completion (ACTUAL)

March 6, 2019

Study Completion (ACTUAL)

March 6, 2019

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (ACTUAL)

March 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173_2018_DexaPOP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe