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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04325984
Enrollment
62
Registered
2020-03-30
Start date
2017-08-29
Completion date
2019-03-06
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Thoracic surgery, Postoperative complications, Dexamethasone, Postoperative Nausea and Vomiting, Hyperglycaemia, Video Assisted ThoracoScopy (VATS), Multimodal Analgesia

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.

Interventions

DRUGDexamethasone

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

Sponsors

University of Trieste
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Morphine consumption24 hours after surgeryMorphine dose, in milligrams, administered in the 24 hours after the surgery

Secondary

MeasureTime frameDescription
Static and dynamic Numeric Rating Scale (NRS)24 hours after surgeryEvaluation of Numeric Rating Scale (NRS) for static and dynamic pain; the NRS uses scores from 0 (no pain) to 10 (worst possible pain)

Other

MeasureTime frameDescription
Glycemic changes24 hours after surgeryEvaluation of intraoperative and postoperative blood glucose levels
Surgical wound infectionAt hospital discharge/ at first medical check if discharge was earlier than 7 daysEvaluation of infectious complication after surgery: assessment of the presence of signs and symptoms of infection of the surgical wound
Postoperative Nausea and Vomiting (PONV)24 hours after surgeryEvaluation of development of postoperative nausea or vomiting, reporting the presence of episodes of nausea or vomiting in the 24 hours after the surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026