Dexamethasone Adverse ReactionNCT04325984
Role of Dexamethasone in Multimodal Analgesia for Postoperative Pain in Thoracic Surgery
An observational study of Dexamethasone Adverse Reaction and Postoperative Pain, run by University of Trieste at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dexamethasone Adverse Reaction, Postoperative Pain, Postoperative Thoracic Procedure Complication
- What is being tested?
- Dexamethasone
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 29 Aug 2017to 6 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted at our surgical center who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS.
Who may be able to join
- BMI < 30 kg/m2
- ASA I-III
- Lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Dexamethasone Adverse Reaction, Postoperative Pain, Postoperative Thoracic Procedure Complication, Analgesia
- Being tested
- Dexamethasone
- Keywords
- Thoracic surgery, Postoperative complications, Dexamethasone, Postoperative Nausea and Vomiting, Hyperglycaemia, Video Assisted ThoracoScopy (VATS), Multimodal Analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia, Postoperative Complications, Postoperative Nausea and Vomiting, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
To the Dexamethasone group, at the moment of the induction of anaesthesia, dexamethasone 8 mg is administered.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Group of patients receiving dexamethasone 8 mg as part of the multimodal analgesia. Receives: Drug: Dexamethasone | |
| Control group | Group of patients receiving multimodal analgesia, not comprising dexamethasone; moreover, ondansetron 4 mg is administered for the control of PONV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Morphine dose, in milligrams, administered in the 24 hours after the surgery
Measured: 24 hours after surgery
Secondary outcomes (1)
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)
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start29 Aug 2017
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dexamethasone Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marzia Umari, University of Trieste
- Investigators
- Umberto Lucangelo, MD PhD, Study director, University of TriesteMarzia Umari, MD, Principal investigator, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325984
- Sponsor's protocol ID
- 173_2018_DexaPOP
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175.
PubMed 21084984Doan 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.
PubMed 25107721Henzi 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.
PubMed 10625002Waldron 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.
PubMed 23220857Kakodkar 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.
PubMed 23848292Standards 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.
PubMed 26696680
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruolo Del Desametasone Per il Controllo Multimodale Del Dolore Postoperatorio in Chirurgia Toracica
- ClinicalTrials.gov ID
- NCT04325984
- Acronym / sponsor ID
- 173_2018_DexaPOP
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | – | Drug: DexamethasoneGroup of patients receiving dexamethasone 8 mg as part of the multimodal analgesia. |
| Control group | – | –Group of patients receiving multimodal analgesia, not comprising dexamethasone; moreover, ondansetron 4 mg is administered for the control of PONV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted at our surgical center who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS.
Key inclusion criteria (3 listed)
- BMI < 30 kg/m2
- ASA I-III
- Lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneTo the Dexamethasone group, at the moment of the induction of anaesthesia, dexamethasone 8 mg is administered. | Drug | Dexamethasone group |
Primary outcome
Morphine consumption
Time frame: 24 hours after surgery
Morphine dose, in milligrams, administered in the 24 hours after the surgery
1 secondary outcome
Static and dynamic Numeric Rating Scale (NRS)
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Background: PubMed 21084984Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175.
- Background: PubMed 25107721Doan 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.
- Background: PubMed 10625002Henzi 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.
- Background: PubMed 23220857Waldron 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.
- Background: PubMed 23848292Kakodkar 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.
- Background: PubMed 26696680Standards 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto Lucangelo, MD PhD study director
University of Trieste
Marzia Umari, MD principal investigator
University of Trieste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dexamethasone Adverse Reaction and Postoperative Pain, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04325984, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.