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Evaluation of Dexketoprofen in Total Knee Arthroplasty

Primary Purpose

Postoperative Pain, Analgesia

Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Dexketoprofen Trometamol
Ropivacaine Hydrochloride 7.5 MG/ML
Sponsored by
KAT General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Elena NikolakopoulouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group IV

Group Periarticular

Group P

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
Total tramadol consumption the first 24hours

Secondary Outcome Measures

Full Information

First Posted
November 9, 2019
Last Updated
November 12, 2019
Sponsor
KAT General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04161690
Brief Title
Evaluation of Dexketoprofen in Total Knee Arthroplasty
Official Title
Evaluation of Dexketoprofen Given Intravenous or Intrathecal in Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KAT General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group IV
Arm Type
Active Comparator
Arm Description
Dexketoprofen 50mg is given intravenous 10 min before the start of the surgery. Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.
Arm Title
Group Periarticular
Arm Type
Active Comparator
Arm Description
Dexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon.
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen Trometamol
Intervention Description
intravenous dexketoprofen 50mg or intrathecal
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hydrochloride 7.5 MG/ML
Intervention Description
Local Infiltration Analgesia
Primary Outcome Measure Information:
Title
VAS Score in 8hours after surgery
Description
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
Title
VAS Score 24hours after surgery
Description
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
Title
VAS Score 48hours after surgery
Description
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
Title
Total tramadol consumption the first 24hours
Time Frame
24h

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Nikolakopoulou
Phone
+306948569999
Email
nikolakopoulou_elena@outlook.com
Facility Information:
Facility Name
Elena Nikolakopoulou
City
Athens
State/Province
Kifissia
ZIP/Postal Code
14561
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Nikolakopoulou
Phone
6948569999
Email
nikolakopoulou_elena@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of Dexketoprofen in Total Knee Arthroplasty

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