NCT00632580

Brief Summary

The purpose of this study is to evaluate the optimal site for application of local anesthetics in total knee arthroplasty surgery. The hypothesis is, that improved pain relief is obtained when administering local anesthetics in the tissues sourrounding the knee joint compared to the knee joint itself.

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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 18, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

February 28, 2008

Last Update Submit

March 17, 2009

Conditions

Pain, Postoperative

Keywords

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • pain

    48 hours

Study Arms (2)

1

ACTIVE COMPARATOR

intraarticular injection with local anesthetic

Drug: intraarticular injection with ropivacaine

2

EXPERIMENTAL

intracapsular injection with local anesthetic

Drug: extraarticular injection with ropivacaine

Interventions

intraarticular injection with ropivacaineDRUG
1
extraarticular injection with ropivacaineDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • eligible for elective total knee arthroplasty
  • able to speak and understand Danish
  • able to give informed consent

You may not qualify if:

  • alocohol or medical abuse
  • allergies to local anesthetics
  • age \< 18 yrs.
  • intolerance to opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Copenhagen, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Injections, Intra-ArticularRopivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeuticsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Lasse Andersen, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 10, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 18, 2009

Record last verified: 2009-03

Locations

DK(1)