Postoperative PainPhase 2NCT04161690
Evaluation of Dexketoprofen in Total Knee Arthroplasty
A Phase 2 study testing Dexketoprofen Trometamol and Ropivacaine Hydrochloride 7.5 MG/ML in people with Postoperative Pain and Analgesia, run by KAT General Hospital at 1 site in Greece.
Trial summary
Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions. Dexketoprofen is a new NSAID treating acute postoperative pain. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Analgesia
- What is being tested?
- Dexketoprofen Trometamol and Ropivacaine Hydrochloride 7.5 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 6 Nov 2019to 30 Nov 2021
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- unilateral total knee arthroplasty
- accept to enter the study
- ASA score I or II
- hospitalization for at least 2 days
Who cannot join
- allergy in any given medications
- active gastrointestinal bleeding or other active bleeding
- history of peptic ulcer
- renal failure
- hepatic failure
- chronic heart failure
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Elena Nikolakopoulou
Athens, Kifissia, 14561
Elena Nikolakopoulou, 6948569999, nikolakopoulou_elena@outlook.com
About this study
Official title: Evaluation of Dexketoprofen Given Intravenous or Intrathecal in Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions. Dexketoprofen is a new NSAID treating acute postoperative pain. The purpose of this study is to evaluate the analgesic effect when it is given intravenously or as part of the local infiltration analgesia in patients under spinal anesthesia undergoing unilateral total knee arthroplasty.
- Conditions
- Postoperative Pain, Analgesia
- Being tested
- Dexketoprofen Trometamol, Ropivacaine Hydrochloride 7.5 MG/ML
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexketoprofen TrometamolDrug
intravenous dexketoprofen 50mg or intrathecal
Ropivacaine Hydrochloride 7.5 MG/MLDrug
Local Infiltration Analgesia
| Study group | Role | What they receive |
|---|---|---|
| Group IV | Active comparator | Dexketoprofen 50mg is given intravenous 10 min before the start of the surgery. Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine. Receives: Drug: Dexketoprofen Trometamol; Drug: Ropivacaine Hydrochloride 7.5 MG/ML |
| Group Periarticular | Active comparator | Dexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon. Receives: Drug: Dexketoprofen Trometamol; Drug: Ropivacaine Hydrochloride 7.5 MG/ML |
| Group P | Placebo comparator | Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine. Receives: Drug: Ropivacaine Hydrochloride 7.5 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Score in 8hours after surgery
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. 10 describes the worst pain that a person ever imagined.
Measured: 8h
VAS Score 24hours after surgery
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Measured: 24h
VAS Score 48hours after surgery
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Measured: 48h
Total tramadol consumption the first 24hours
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start6 Nov 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KAT General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Nikolakopoulou, KAT General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161690
- Sponsor's protocol ID
- 13022
- Status last verified
- Nov 2019
- First submitted
- 9 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dexketoprofen Given Intravenous or Intrathecal in Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04161690
- Acronym / sponsor ID
- 13022
- Conditions
- Postoperative Pain, Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KAT General HospitalUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 13 Nov 2019 (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.
Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions. Dexketoprofen is a new NSAID treating acute postoperative pain. The purpose of this study is to evaluate the analgesic effect when it is given intravenously or as part of the local infiltration analgesia in patients under spinal anesthesia undergoing unilateral total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group IV | Active comparator | Drug: Dexketoprofen Trometamol, Drug: Ropivacaine Hydrochloride 7.5 MG/MLDexketoprofen 50mg is given intravenous 10 min before the start of the surgery. Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine. |
| Group Periarticular | Active comparator | Drug: Dexketoprofen Trometamol, Drug: Ropivacaine Hydrochloride 7.5 MG/MLDexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon. |
| Group P | Placebo comparator | Drug: Ropivacaine Hydrochloride 7.5 MG/MLLocal infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral total knee arthroplasty
- accept to enter the study
- ASA score I or II
- hospitalization for at least 2 days
Key exclusion criteria (6 listed)
- allergy in any given medications
- active gastrointestinal bleeding or other active bleeding
- history of peptic ulcer
- renal failure
- hepatic failure
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 |
|---|---|---|
| Dexketoprofen Trometamolintravenous dexketoprofen 50mg or intrathecal | Drug | Group IV, Group Periarticular |
| Ropivacaine Hydrochloride 7.5 MG/MLLocal Infiltration Analgesia | Drug | Group IV, Group P, Group Periarticular |
Primary outcome
VAS Score in 8hours after surgery
Time frame: 8h
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. 10 describes the worst pain that a person ever imagined.
VAS Score 24hours after surgery
Time frame: 24h
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
VAS Score 48hours after surgery
Time frame: 48h
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Total tramadol consumption the first 24hours
Time frame: 24h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexketoprofen Trometamol and Ropivacaine Hydrochloride 7.5 MG/ML in people with Postoperative Pain and Analgesia, run by KAT General Hospital at 1 site in Greece.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. 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 Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Nikolakopoulou (+306948569999, nikolakopoulou_elena@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Score in 8hours after surgery (time frame: 8h). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2019.