Evaluation of Dexketoprofen in Total Knee Arthroplasty

NCT ID: NCT04161690

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-06

Study Completion Date

2021-11-30

Brief Summary

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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

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Conditions

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Postoperative Pain Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Dexketoprofen Trometamol

Intervention Type DRUG

intravenous dexketoprofen 50mg or intrathecal

Ropivacaine Hydrochloride 7.5 MG/ML

Intervention Type DRUG

Local Infiltration Analgesia

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.

Group Type ACTIVE_COMPARATOR

Dexketoprofen Trometamol

Intervention Type DRUG

intravenous dexketoprofen 50mg or intrathecal

Ropivacaine Hydrochloride 7.5 MG/ML

Intervention Type DRUG

Local Infiltration Analgesia

Group P

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

Group Type PLACEBO_COMPARATOR

Ropivacaine Hydrochloride 7.5 MG/ML

Intervention Type DRUG

Local Infiltration Analgesia

Interventions

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Dexketoprofen Trometamol

intravenous dexketoprofen 50mg or intrathecal

Intervention Type DRUG

Ropivacaine Hydrochloride 7.5 MG/ML

Local Infiltration Analgesia

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KAT General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elena Nikolakopoulou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Elena Nikolakopoulou

Athens, Kifissia, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Elena Nikolakopoulou

Role: CONTACT

+306948569999

Facility Contacts

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Elena Nikolakopoulou

Role: primary

6948569999

Other Identifiers

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13022

Identifier Type: -

Identifier Source: org_study_id

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