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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325984
• Other study ID #: 173_2018_DexaPOP
• Status: Completed
• Start date: August 29, 2017
• Est. completion date: March 6, 2019

Study information

• Verified date: March 2020
• Source: University of Trieste
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 6, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Cattinara Hospital	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
University of Trieste

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. Review. — View Citation

Henzi I, Walder B, Tramèr MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000 Jan;90(1):186-94. — View 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. — View 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. Review. — View 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. Review. — View Citation

Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glycemic changes	Evaluation of intraoperative and postoperative blood glucose levels	24 hours after surgery
Other	Surgical wound infection	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
Other	Postoperative Nausea and Vomiting (PONV)	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
Primary	Morphine consumption	Morphine dose, in milligrams, administered in the 24 hours after the surgery	24 hours after surgery
Secondary	Static and dynamic Numeric Rating Scale (NRS)	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

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