NCT04161690

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2 postoperative-pain

Timeline
Completed

Started Nov 2019

Longer than P75 for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

November 9, 2019

Last Update Submit

November 12, 2019

Conditions

Postoperative PainAnalgesia

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (3)

Group IV

ACTIVE COMPARATOR

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 TrometamolDrug: Ropivacaine Hydrochloride 7.5 MG/ML

Group Periarticular

ACTIVE COMPARATOR

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 TrometamolDrug: Ropivacaine Hydrochloride 7.5 MG/ML

Group P

PLACEBO COMPARATOR

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

Drug: Ropivacaine Hydrochloride 7.5 MG/ML

Interventions

Dexketoprofen TrometamolDRUG

intravenous dexketoprofen 50mg or intrathecal

Group IVGroup Periarticular
Ropivacaine Hydrochloride 7.5 MG/MLDRUG

Local Infiltration Analgesia

Group IVGroup PGroup Periarticular

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral total knee arthroplasty
  • accept to enter the study
  • ASA score I or II
  • hospitalization for at least 2 days

You may not qualify if:

  • allergy in any given medications
  • active gastrointestinal bleeding or other active bleeding
  • history of peptic ulcer
  • renal failure
  • hepatic failure
  • chronic heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elena Nikolakopoulou

Athens, Kifissia, 14561, Greece

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

dexketoprofen trometamolRopivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Elena Nikolakopoulou

CONTACT

+306948569999nikolakopoulou_elena@outlook.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2019

First Posted

November 13, 2019

Study Start

November 6, 2019

Primary Completion

November 30, 2020

Study Completion

November 30, 2021

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

GR(1)