Postoperative PainPhase 4DEX-2-TKANCT03506789
Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty
A Phase 4 study testing Dexamethasone in people with Postoperative Pain, run by Naestved Hospital at 5 sites in Denmark.
Trial summary
Dexamethasone twice for pain treatment after total knee arthroplasty - A Placebo-controlled, randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for postoperative treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 485 participants
- Where
- 5 sitesDenmark
- Study dates
- 14 Sep 2018to 7 Jun 2020
- Phase
- Phase 4
- 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
Who may be able to join
- Scheduled for unilateral, primary total knee arthroplasty
- ASA 1-3
- BMI ≥ 18.0 and ≤ 40.0
- Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age
- Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions
Who cannot join
- Patients who cannot cooperate with the trial
- Concomitant participation in another trial involving medication
- Patients who cannot understand or speak Danish
- Patients with allergy to medication used in the trial
- Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids.
- Patients with at daily use of systemic glucocorticoids
Show all 9Show fewer
- Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 bil/l); or against treatment with glucocorticoids.
- Dysregulated diabetes (investigators judgement)
- Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Gildhøj Privathospital
Brøndby, 2605
Bispebjerg Hospital
Copenhagen, 2400
Sjællands Universitetshospital, Køge
Køge, 4600
Næstsved Sygehus
Næstved, 4700
Odense Universitetshospital
Odense, 5000
About this study
Official title: Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty - A Randomized Blinded Placebo-controlled Clinical Trial
Dexamethasone twice for pain treatment after total knee arthroplasty - A Placebo-controlled, randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for postoperative treatment
Read the detailed description
Trial name: Dexamethasone twice for pain treatment of total knee arthroplasty - A randomized blinded placebo-controlled clinical trial
Trial Acronym: DEX-2-TKA
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists for pain treatment after total knee arthroplasty (TKA) since combinations of different analgesic treatments are used with nearly no evidence for combined analgesic efficacy. A single perioperative dose of glucocorticoid (GCC) (i.e. dexamethasone) has well established effects on postoperative nausea and vomiting, and may be beneficial for postoperative pain. A recent trial suggested that an additional postoperative dose of GCC improved postoperative pain treatment. Recent systematic reviews, sub-studies of RCTs and cohort studies of perioperative GCC raised no concern regarding serious adverse events of a single dose GCC for non-cardiac surgery. However, optimal dose, combination and regimen of perioperative GCC remains unsettled.
Objective: To establish the analgesic effect and safety of one and two consecutive days of a single dose of dexamethasone after TKA. GCC will be administered in combination with paracetamol, NSAID (ibuprofen), and local infiltration analgesia.
Intervention: The participants will be randomised in three groups: A) 24 mg dexamethasone i.v. perioperative (POD0) and 24 mg dexamethasone i.v. on the first postoperative day (POD1); B) 24 mg dexamethasone i.v. POD0 and placebo (isotonic saline) i.v. on POD1; and C) placebo i.v. on POD0 and POD1.
Design and trial size: Placebo-controlled, randomised, parallel 3-group multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with unknown block size. Assessor, investigator, caregivers and participants will all be blinded. A total of 423 eligible participants are needed to detect a difference of 10 mg morphine for the first 48 hours postoperatively with a standard deviation of 23 mg, an overall familywise type 1 error rate of 0.05 and a type 2 error rate of 0.10. To compensate for uncertainty of the distribution a surplus of 15 % is added, thus a total of 486 patients will be included. To maintain an overall familywise error rate of 0.05 the sample size estimation is based on pairwise comparisons of the primary outcome between the three groups (three comparisons) with an individual type I error rate of 0.0167.
Sub studies: The investigators plan the following substudies
- One-year follow-up with EQ-5D-5L (EuroQuols - 5 dimension - 5 level score), Oxford-Knee-Score and mortality including need for medical attention.
- Troponin (TnI) levels 24 and 48 hours postoperatively (only at Naestved Hospital).
- Analysis of high and low pain responders.
- Establishment of a bio-bank (blood-samples) for future studies (only at Naestved Hospital).
Due to decisions made by the Steering Committee at our meeting the 14th of May 2019 in Køge, Region Zealand, Denmark, the secondary outcomes have been rearranged and divided into secondary outcomes and other (eksplorative) outcomes. Furthermore an additional explorative endpoint is added: Number of patients with a permanent use of opioids 90 days after surgery.
No data was unblinded or analyzed to aid the decisions.
After the last patient was included, but prior to data analysis and unmasking, the Steering Committee decided to include the following explorative outcomes in the main article reporting results from this trial. The decision was made by consensus via email 4th of October 2020:
- proportion of participants with one or more severe adverse event (SAE), including death, within 90 days after surgery (SAE defined according to ICH-GCP-guidelines, except 'prolongation of hospitalisation')
- opioid related adverse events (AE)
- level of nausea, sedation and dizziness at 24 and 48 h
- number of vomiting episodes 0-24 and 24-48 h"
- use of anti-emetics 0-24 and 24-48 h
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone, Placebos
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone 24 mg
PlacebosDrug
Isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: | Active comparator | 24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day Receives: Drug: Dexamethasone |
| Treatment B: | Active comparator | 24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day Receives: Drug: Dexamethasone; Drug: Placebos |
| Placebo | Placebo comparator | Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative usage of morphine 0-48 hours postoperatively
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively.
Consumption in mg
Measured: 0-48 hours postoperatively
Secondary outcomes (2)
VAS-pain scores (visual analogue scale (VAS))
- with active 45 degrees flexion of the knee (VAS) at 24 and 48 hours postoperatively
- at rest at 24 and 48 hours postoperatively
- highest score during 0-24 hours and 24-48 hours
Measured: 24 and 48 hours postoperatively
Adverse events, patient-reported
Number of patients with one or more patient-reported adverse event in the intervention period
Measured: 0-48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start14 Sep 2018
- Primary completion11 Mar 2020
- Study completion7 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ole Mathiesen, MD, PhD, Assoc Prof, Study chair, Department of Anaesthesiology, Zealand University Hospital, KøgeDaniel Hägi-Pedersen, MD, PhD, Study chair, Department of Anaesthesiology, Næstved HospitalJørgen B Dahl, DMSc, Study chair, Department of Anaesthesiology, Bispebjerg HospitalKasper S Gasbjerg, MD, Principal investigator, Department of Anaesthesiology, Næstved HospitalTroels H Lunn, DMSc, Study chair, Department of Anaesthesiology, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506789
- Sponsor's protocol ID
- SM1-KAKG-2018
- Acronym
- DEX-2-TKA
- Status last verified
- Oct 2020
- First submitted
- 21 Feb 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will also be published anonymised according to ICIMEs (International Committee of Medical Journal Editors) guidelines
Publications
Molgaard AK, Gasbjerg KS, Mathiesen O, Hagi-Pedersen D, Gogenur I. Dexamethasone vs. placebo modulation of the perioperative blood immune proteome in patients undergoing total knee arthroplasty. BMC Anesthesiol. 2025 Mar 21;25(1):136. doi: 10.1186/s12871-025-03003-3.
PubMed 40119286Derby CB, Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Pedersen NA, Lindholm P, Brorson S, Schroder HM, Thybo KH, Bagger J, Lindberg-Larsen M, Overgaard S, Jakobsen JC, Mathiesen O. Prolonged effects of dexamethasone following total knee arthroplasty: A pre-planned sub-study of the DEX-2-TKA trial. Acta Anaesthesiol Scand. 2024 Jan;68(1):35-42. doi: 10.1111/aas.14319. Epub 2023 Sep 14.
PubMed 37709280Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Laursen CC, Holmqvist M, Vinstrup LO, Ammitzboell M, Jakobsen K, Jensen MS, Pallesen MJ, Bagger J, Lindholm P, Pedersen NA, Schroder HM, Lindberg-Larsen M, Norskov AK, Thybo KH, Brorson S, Overgaard S, Jakobsen JC, Mathiesen O. Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial. BMJ. 2022 Jan 4;376:e067325. doi: 10.1136/bmj-2021-067325.
PubMed 34983775Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Overgaard S, Pedersen NA, Bagger J, Lindholm P, Brorson S, Schroder HM, Thybo KH, Mathiesen O, Jakobsen JC. DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty: Detailed statistical analysis plan for a randomized, blinded, three-group multicentre clinical trial. Acta Anaesthesiol Scand. 2020 Jul;64(6):839-846. doi: 10.1111/aas.13560. Epub 2020 Mar 3.
PubMed 32048274Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Jakobsen JC, Overgaard S, Pedersen NA, Bagger J, Lindholm P, Brorson S, Schroder HM, Thybo KH, Mathiesen O. DEX-2-TKA-DEXamethasone twice for pain treatment after Total Knee Arthroplasty: A protocol for a randomized, blinded, three-group multicentre clinical trial. Acta Anaesthesiol Scand. 2020 Feb;64(2):267-275. doi: 10.1111/aas.13481. Epub 2019 Oct 18.
PubMed 31544230
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty - A Randomized Blinded Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03506789
- Acronym / sponsor ID
- DEX-2-TKA / SM1-KAKG-2018
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 24 Apr 2018 (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.
Dexamethasone twice for pain treatment after total knee arthroplasty - A Placebo-controlled, randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for postoperative treatment
Detailed description
Trial name: Dexamethasone twice for pain treatment of total knee arthroplasty - A randomized blinded placebo-controlled clinical trial
Trial Acronym: DEX-2-TKA
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists for pain treatment after total knee arthroplasty (TKA) since combinations of different analgesic treatments are used with nearly no evidence for combined analgesic efficacy. A single perioperative dose of glucocorticoid (GCC) (i.e. dexamethasone) has well established effects on postoperative nausea and vomiting, and may be beneficial for postoperative pain. A recent trial suggested that an additional postoperative dose of GCC improved postoperative pain treatment. Recent systematic reviews, sub-studies of RCTs and cohort studies of perioperative GCC raised no concern regarding serious adverse events of a single dose GCC for non-cardiac surgery. However, optimal dose, combination and regimen of perioperative GCC remains unsettled.
Objective: To establish the analgesic effect and safety of one and two consecutive days of a single dose of dexamethasone after TKA. GCC will be administered in combination with paracetamol, NSAID (ibuprofen), and local infiltration analgesia.
Intervention: The participants will be randomised in three groups: A) 24 mg dexamethasone i.v. perioperative (POD0) and 24 mg dexamethasone i.v. on the first postoperative day (POD1); B) 24 mg dexamethasone i.v. POD0 and placebo (isotonic saline) i.v. on POD1; and C) placebo i.v. on POD0 and POD1.
Design and trial size: Placebo-controlled, randomised, parallel 3-group multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with unknown block size. Assessor, investigator, caregivers and participants will all be blinded. A total of 423 eligible participants are needed to detect a difference of 10 mg morphine for the first 48 hours postoperatively with a standard deviation of 23 mg, an overall familywise type 1 error rate of 0.05 and a type 2 error rate of 0.10. To compensate for uncertainty of the distribution a surplus of 15 % is added, thus a total of 486 patients will be included. To maintain an overall familywise error rate of 0.05 the sample size estimation is based on pairwise comparisons of the primary outcome between the three groups (three comparisons) with an individual type I error rate of 0.0167.
Sub studies: The investigators plan the following substudies
- One-year follow-up with EQ-5D-5L (EuroQuols - 5 dimension - 5 level score), Oxford-Knee-Score and mortality including need for medical attention.
- Troponin (TnI) levels 24 and 48 hours postoperatively (only at Naestved Hospital).
- Analysis of high and low pain responders.
- Establishment of a bio-bank (blood-samples) for future studies (only at Naestved Hospital).
Due to decisions made by the Steering Committee at our meeting the 14th of May 2019 in Køge, Region Zealand, Denmark, the secondary outcomes have been rearranged and divided into secondary outcomes and other (eksplorative) outcomes. Furthermore an additional explorative endpoint is added: Number of patients with a permanent use of opioids 90 days after surgery.
No data was unblinded or analyzed to aid the decisions.
After the last patient was included, but prior to data analysis and unmasking, the Steering Committee decided to include the following explorative outcomes in the main article reporting results from this trial. The decision was made by consensus via email 4th of October 2020:
- proportion of participants with one or more severe adverse event (SAE), including death, within 90 days after surgery (SAE defined according to ICH-GCP-guidelines, except 'prolongation of hospitalisation')
- opioid related adverse events (AE)
- level of nausea, sedation and dizziness at 24 and 48 h
- number of vomiting episodes 0-24 and 24-48 h"
- use of anti-emetics 0-24 and 24-48 h
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: | Active comparator | Drug: Dexamethasone24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day |
| Treatment B: | Active comparator | Drug: Dexamethasone, Drug: Placebos24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled for unilateral, primary total knee arthroplasty
- ASA 1-3
- BMI ≥ 18.0 and ≤ 40.0
- Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age
- Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions
Key exclusion criteria (9 listed)
- Patients who cannot cooperate with the trial
- Concomitant participation in another trial involving medication
- Patients who cannot understand or speak Danish
- Patients with allergy to medication used in the trial
- Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids.
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 |
|---|---|---|
| DexamethasoneDexamethasone 24 mg | Drug | Treatment A:, Treatment B: |
| PlacebosIsotonic saline | Drug | Placebo, Treatment B: |
Primary outcome
Cumulative usage of morphine 0-48 hours postoperatively
Time frame: 0-48 hours postoperatively
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg
2 secondary outcomes
VAS-pain scores (visual analogue scale (VAS))
Time frame: 24 and 48 hours postoperatively
Adverse events, patient-reported
Time frame: 0-48 hours postoperatively
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 8 Oct 2020.
- Derived from this study: PubMed 40119286Molgaard AK, Gasbjerg KS, Mathiesen O, Hagi-Pedersen D, Gogenur I. Dexamethasone vs. placebo modulation of the perioperative blood immune proteome in patients undergoing total knee arthroplasty. BMC Anesthesiol. 2025 Mar 21;25(1):136. doi: 10.1186/s12871-025-03003-3.
- Derived from this study: PubMed 37709280Derby CB, Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Pedersen NA, Lindholm P, Brorson S, Schroder HM, Thybo KH, Bagger J, Lindberg-Larsen M, Overgaard S, Jakobsen JC, Mathiesen O. Prolonged effects of dexamethasone following total knee arthroplasty: A pre-planned sub-study of the DEX-2-TKA trial. Acta Anaesthesiol Scand. 2024 Jan;68(1):35-42. doi: 10.1111/aas.14319. Epub 2023 Sep 14.
- Derived from this study: PubMed 34983775Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Laursen CC, Holmqvist M, Vinstrup LO, Ammitzboell M, Jakobsen K, Jensen MS, Pallesen MJ, Bagger J, Lindholm P, Pedersen NA, Schroder HM, Lindberg-Larsen M, Norskov AK, Thybo KH, Brorson S, Overgaard S, Jakobsen JC, Mathiesen O. Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial. BMJ. 2022 Jan 4;376:e067325. doi: 10.1136/bmj-2021-067325.
- Derived from this study: PubMed 32048274Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Overgaard S, Pedersen NA, Bagger J, Lindholm P, Brorson S, Schroder HM, Thybo KH, Mathiesen O, Jakobsen JC. DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty: Detailed statistical analysis plan for a randomized, blinded, three-group multicentre clinical trial. Acta Anaesthesiol Scand. 2020 Jul;64(6):839-846. doi: 10.1111/aas.13560. Epub 2020 Mar 3.
- Derived from this study: PubMed 31544230Gasbjerg KS, Hagi-Pedersen D, Lunn TH, Jakobsen JC, Overgaard S, Pedersen NA, Bagger J, Lindholm P, Brorson S, Schroder HM, Thybo KH, Mathiesen O. DEX-2-TKA-DEXamethasone twice for pain treatment after Total Knee Arthroplasty: A protocol for a randomized, blinded, three-group multicentre clinical trial. Acta Anaesthesiol Scand. 2020 Feb;64(2):267-275. doi: 10.1111/aas.13481. Epub 2019 Oct 18.
- Individual participant dataSharing planned: Yes. Data will also be published anonymised according to ICIMEs (International Committee of Medical Journal Editors) guidelines
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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.
Ole Mathiesen, MD, PhD, Assoc Prof study chair
Department of Anaesthesiology, Zealand University Hospital, Køge
Daniel Hägi-Pedersen, MD, PhD study chair
Department of Anaesthesiology, Næstved Hospital
Jørgen B Dahl, DMSc study chair
Department of Anaesthesiology, Bispebjerg Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Postoperative Pain, run by Naestved Hospital at 5 sites in Denmark.
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 5 inclusion and 9 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cumulative usage of morphine 0-48 hours postoperatively (time frame: 0-48 hours postoperatively). 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 NCT03506789, which also lists 5 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 8 Oct 2020.