NCT04161690 - Evaluation of Dexketoprofen in Total Knee Arthroplasty | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Postoperative Pain Analgesia

Interventions

Dexketoprofen TrometamolDRUG

intravenous dexketoprofen 50mg or intrathecal

Ropivacaine Hydrochloride 7.5 MG/MLDRUG

Local Infiltration Analgesia

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Elena Nikolakopoulou

Athens, Kifissia, Greece

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 48h

Total tramadol consumption the first 24hours

Time frame: 24h

Central Contacts

Elena Nikolakopoulou

CONTACT

+306948569999 nikolakopoulou_elena@outlook.com