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

NCT04325984 | Completed

• 1 other identifier: 173_2018_DexaPOP
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

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

  24 hours after surgery

Secondary Outcomes (1)

• Static and dynamic Numeric Rating Scale (NRS)

  24 hours after surgery

Other Outcomes (3)

• Glycemic changes

  24 hours after surgery

• Surgical wound infection

  At hospital discharge/ at first medical check if discharge was earlier than 7 days

• Postoperative Nausea and Vomiting (PONV)

  24 hours after surgery

Study Arms (2)

Dexamethasone group

Group of patients receiving dexamethasone 8 mg as part of the multimodal analgesia.

Drug: Dexamethasone

Control group

Group of patients receiving multimodal analgesia, not comprising dexamethasone; moreover, ondansetron 4 mg is administered for the control of PONV.

Interventions

Dexamethasone DRUG

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

Dexamethasone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• BMI \< 30 kg/m2
• ASA I-III
• Lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Cattinara Hospital

Trieste, 34149, Italy

Location

Related Publications (6)

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

  PMID: 21084984 BACKGROUND

• 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.

  PMID: 25107721 BACKGROUND

• 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.

  PMID: 10625002 BACKGROUND

• 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.

  PMID: 23220857 BACKGROUND

• 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.

  PMID: 23848292 BACKGROUND

• 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.

  PMID: 26696680 BACKGROUND

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MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Postoperative Complications; Postoperative Nausea and Vomiting; Hyperglycemia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Nausea; Signs and Symptoms, Digestive; Vomiting; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Umberto Lucangelo, MD PhD

  University of Trieste

  STUDY DIRECTOR

• Marzia Umari, MD

  University of Trieste

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 30, 2020
• Study Start: August 29, 2017
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

IT (1)