Evaluation of Dexketoprofen in Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161690
• Other study ID #: 13022
• Status: Recruiting
• Phase: Phase 2
• Start date: November 6, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2019
• Source: KAT General Hospital
• Contact: Elena Nikolakopoulou
• Phone: +306948569999
• Email: nikolakopoulou_elena[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexketoprofen Trometamol
intravenous dexketoprofen 50mg or intrathecal
• Ropivacaine Hydrochloride 7.5 MG/ML
Local Infiltration Analgesia

Locations

Country	Name	City	State
Greece	Elena Nikolakopoulou	Athens	Kifissia

Sponsors (1)

Lead Sponsor	Collaborator
KAT General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8h
Primary	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.	24h
Primary	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.	48h
Primary	Total tramadol consumption the first 24hours		24h