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Clinical Trials/EUCTR2009-013396-22-DK
EUCTR2009-013396-22-DK
Active, not recruiting
Not Applicable

/A - Serumkoncentrationsstudie

Odense Universitetshospital/Syddansk Universitet0 sites25 target enrollmentJuly 6, 2009
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ConditionsFor at evaluere sikkerheden og muligheden for dosisoptimering ved topisk administreret ropivacain, ønsker vi at måle serumkoncentrationen af lægemidlet i blodprøver fra patienter, der behandles med gentagne bolusinjektioner med ropivacain som postoperativ smertebehandling efter osteosyntese (operation med skruer og skinner) af hoftenært lårbensbrud af pertrochantær type.MedDRA version: 9.1Level: LLTClassification code 10034736Term: Pertrochanteric fracture of femur, closed
DrugsNaropin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
For at evaluere sikkerheden og muligheden for dosisoptimering ved topisk administreret ropivacain, ønsker vi at måle serumkoncentrationen af lægemidlet i blodprøver fra patienter, der behandles med gentagne bolusinjektioner med ropivacain som postoperativ smertebehandling efter osteosyntese (operation med skruer og skinner) af hoftenært lårbensbrud af pertrochantær type.
Sponsor
Odense Universitetshospital/Syddansk Universitet
Enrollment
25
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 6, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Odense Universitetshospital/Syddansk Universitet

Eligibility Criteria

Inclusion Criteria

  • •Pertrochantær femurfraktur og indikation for DHS\-osteosyntese.
  • •Hver patient kan kun indgå med 1 hoftefraktur.
  • •Patienterne skal have gangfunktion (patienten angiver normalt at kunne gå med eller uden hjælpemidler).
  • •Kun frakturer opstået ved lavenergitraumer kan indgå.
  • •Patienterne skal kunne forstå dansk og være i stand til selv at give informeret samtykke. Patienter med OMC \< 8 (kognitiv test) kan ikke deltage.
  • •Patienter med hoftenær lavenergifraktur er typisk ældre end 60 år gamle. Det er ikke sandsynligt, at patientgruppens kvinder er fertile. Skulle en kvinde i den fertile alder inkluderes i projektet, skal der inden inklusion i forsøget foretages graviditetstest, som skal være negativ
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •Inverse frakturer ekskluderes.
  • •Fast forbrug af opioider.
  • •Allergi mod lokalanalgetika.
  • •Inflammatorisk ledlidelse.
  • •Patologiske frakturer.

Outcomes

Primary Outcomes

Not specified

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