Evaluation of Dexketoprofen in Total Knee Arthroplasty

Phase 2

• Conditions: Analgesia; Postoperative Pain
• Interventions: Drug: Dexketoprofen Trometamol; Drug: Ropivacaine Hydrochloride 7.5 MG/ML

• Registration Number: NCT04161690
• Lead Sponsor: KAT General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-06
• Study First Submitted: 2019-11-09
• Study First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Study First Posted: 2019-11-13
• Last Update Posted: 2019-11-13
• Primary Completion: 2020-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group IV	Dexketoprofen Trometamol	Dexketoprofen 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	Dexketoprofen Trometamol	Dexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon.
Group Periarticular	Ropivacaine Hydrochloride 7.5 MG/ML	Dexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon.
Group P	Ropivacaine Hydrochloride 7.5 MG/ML	Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.
Group IV	Ropivacaine Hydrochloride 7.5 MG/ML	Dexketoprofen 50mg is given intravenous 10 min before the start of the surgery. Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.

Primary Outcome Measures

Name	Time	Method
VAS Score in 8hours after surgery	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.
Total tramadol consumption the first 24hours	24h
VAS Score 24hours after surgery	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	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.

Trial Locations

Locations (1)

Elena Nikolakopoulou; 🇬🇷 Athens, Kifissia, Greece