CClinicalTrials.gg
Status unknownNCT04161690Updated Nov 13, 2019

Evaluation of Dexketoprofen in Total Knee Arthroplasty

A Phase 2 interventional study of Dexketoprofen Trometamol and Ropivacaine Hydrochloride 7.5 MG/ML in Postoperative Pain and Analgesia, sponsored by KAT General Hospital. Status unknown at 1 site in Greece. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by KAT General Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
All
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Study 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. 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.

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Conditions studied

  • Postoperative Pain
  • Analgesia

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In context

Pain, Postoperative

5,095 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 120 is above the median of 75 across 4,346 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

KAT General Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • unilateral total knee arthroplasty
  • accept to enter the study
  • ASA score I or II
  • hospitalization for at least 2 days

Exclusion criteria

Exclusion Criteria:

  • allergy in any given medications
  • active gastrointestinal bleeding or other active bleeding
  • history of peptic ulcer
  • renal failure
  • hepatic failure
  • chronic heart failure
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Group IV

    Dexketoprofen 50mg is given intravenous 10 min before the start of the surgery. Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.

    Drug: Dexketoprofen Trometamol · Drug: Ropivacaine Hydrochloride 7.5 MG/ML

  • Active comparator
    Group Periarticular

    Dexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon.

    Drug: Dexketoprofen Trometamol · Drug: Ropivacaine Hydrochloride 7.5 MG/ML

  • Placebo comparator
    Group P

    Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.

    Drug: Ropivacaine Hydrochloride 7.5 MG/ML

Interventions

  • DrugDexketoprofen Trometamol

    intravenous dexketoprofen 50mg or intrathecal

  • DrugRopivacaine Hydrochloride 7.5 MG/ML

    Local Infiltration Analgesia

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8h

  2. 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.

    Time frame: 24h

  3. 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.

    Time frame: 48h

  4. Total tramadol consumption the first 24hours

    Time frame: 24h

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04161690
Lead sponsor
KAT General Hospital
Responsible party
Elena Nikolakopoulou (Principal Investigator, KAT General Hospital) — Principal investigator
First posted
Nov 13, 2019
Start date
Nov 6, 2019
Primary completion
Nov 30, 2020 (estimated)
Completion
Nov 30, 2021 (estimated)
Last update
Nov 13, 2019

Study contacts

Elena Nikolakopoulou
Contact
nikolakopoulou_elena@outlook.com
+306948569999

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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