Evaluation of Dexketoprofen in Total Knee Arthroplasty

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Analgesia
• Intervention / Treatment: Drug: Dexketoprofen Trometamol; Drug: Ropivacaine Hydrochloride 7.5 MG/ML

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Elena Nikolakopoulou; Phone Number: +306948569999; Email: nikolakopoulou_elena@outlook.com

Study Locations

• Greece
  • Kifissia
    • Athens, Kifissia, Greece, 14561
      • Recruiting
      • Elena Nikolakopoulou
      • Contact: Elena Nikolakopoulou; Phone Number: 6948569999; Email: nikolakopoulou_elena@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; intravenous dexketoprofen 50mg or intrathecal; Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Local Infiltration Analgesia
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; intravenous dexketoprofen 50mg or intrathecal; Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Local Infiltration Analgesia
Placebo Comparator: Group P; Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.	Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Local Infiltration Analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Total tramadol consumption the first 24hours		24h

Collaborators and Investigators

• Sponsor: KAT General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: November 9, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anesthetics, Local; Ropivacaine; Dexketoprofen trometamol
• Other Study ID Numbers: 13022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No