Clinical trial NCT04325984: Role of Dexamethasone in Multimodal Analgesia for Postoperative Pain in Thoracic Surgery
Official title: Ruolo Del Desametasone Per il Controllo Multimodale Del Dolore Postoperatorio in Chirurgia Toracica
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dexamethasone Adverse Reaction
Postoperative Pain
Postoperative Thoracic Procedure Complication
Analgesia
Keywords: Thoracic surgery
Postoperative complications
Dexamethasone
Postoperative Nausea and Vomiting
Hyperglycaemia
Video Assisted ThoracoScopy (VATS)
Multimodal Analgesia
Lead sponsor: University of Trieste
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Static and dynamic Numeric Rating Scale (NRS)
timeFrame: 24 hours after surgery
Other outcomes:
measure: Glycemic changes
timeFrame: 24 hours after surgery
measure: Surgical wound infection
timeFrame: At hospital discharge/ at first medical check if discharge was earlier than 7 days
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: 24 hours after surgery
Locations:
city: Trieste
country: Italy
facility: Cattinara Hospital
Study officials:
affiliation: University of Trieste
name: Umberto Lucangelo, MD PhD
role: STUDY_DIRECTOR
affiliation: University of Trieste
name: Marzia Umari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175.
citation: Doan LV, Augustus J, Androphy R, Schechter D, Gharibo C. Mitigating the impact of acute and chronic post-thoracotomy pain. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):1048-56. doi: 10.1053/j.jvca.2014.02.021. No abstract available.
citation: Henzi I, Walder B, Tramer MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000 Jan;90(1):186-94. doi: 10.1097/00000539-200001000-00038.
citation: Waldron NH, Jones CA, Gan TJ, Allen TK, Habib AS. Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. Br J Anaesth. 2013 Feb;110(2):191-200. doi: 10.1093/bja/aes431. Epub 2012 Dec 5.
citation: Kakodkar PS. Routine use of dexamethasone for postoperative nausea and vomiting: the case for. Anaesthesia. 2013 Sep;68(9):889-91. doi: 10.1111/anae.12308. Epub 2013 Jul 15. No abstract available.
citation: Standards of Medical Care in Diabetes-2016: Summary of Revisions. Diabetes Care. 2016 Jan;39 Suppl 1:S4-5. doi: 10.2337/dc16-S003. No abstract available.