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Evaluation of Dexketoprofen in Total Knee Arthroplasty

Evaluation of Dexketoprofen Given Intravenous or Intrathecal in Postoperative Pain in Patients Undergoing Total Knee Arthroplasty

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04161690
Enrollment
120
Registered
2019-11-13
Start date
2019-11-06
Completion date
2021-11-30
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Analgesia

Brief 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.

Interventions

intravenous dexketoprofen 50mg or intrathecal

Local Infiltration Analgesia

Sponsors

KAT General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
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

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

Design outcomes

Primary

MeasureTime frameDescription
VAS Score in 8hours after surgery8hThe 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 surgery24hThe 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 surgery48hThe 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 24hours24h

Countries

Greece

Contacts

Primary ContactElena Nikolakopoulou
nikolakopoulou_elena@outlook.com+306948569999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026