NCT00408707

Brief Summary

The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2006

Completed
Last Updated

February 29, 2008

Status Verified

February 1, 2008

First QC Date

December 6, 2006

Last Update Submit

February 28, 2008

Conditions

Postoperative Pain

Keywords

local infiltration analgesiapostoperative painropivacaine

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

Secondary Outcomes (2)

  • analgésia consumption

  • time to discharge

Interventions

local infiltration analgesiaPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • patients eligible for total knee arthroplasty
  • must speak and understand Danish
  • must be able to give oral and written consent

You may not qualify if:

  • Alcohol or medicine abuse
  • Treatment with opioids
  • Allergy to local anaesthetics
  • Severe obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.

    PMID: 19025523DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Lasse Andersen, M.D.

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2006

First Posted

December 7, 2006

Study Start

September 1, 2006

Study Completion

December 1, 2006

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

DK(1)