NCT00518674

Brief Summary

The aim of this randomized, double-blind and placebo-controlled study is to evaluate the specific role of injection of local anesthetic into the intra- vs. extraarticular tissues after toal knee arthroplasty.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2007

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, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 21, 2007

Status Verified

July 1, 2007

First QC Date

August 20, 2007

Last Update Submit

August 20, 2007

Conditions

Postoperative Pain

Keywords

painlocal infiltration analgesia

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale pain score

Interventions

local infiltration analgesiaPROCEDURE

local wound infiltration with 30 ml ropivacaine 0.2 % (60 mg)

Eligibility Criteria

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

You may qualify if:

  • Able to give informed oral and written consent to participate
  • Able to speak Danish

You may not qualify if:

  • Treatment with opioids
  • Body Mass Index \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Andersen LO, Kristensen BB, Madsen JL, Otte KS, Husted H, Kehlet H. Wound spread of radiolabeled saline with multi- versus few-hole catheters. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):200-2. doi: 10.1097/aap.0b013e3181c7733d.

    PMID: 20301825DERIVED

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Lasse Andersen, MD

    Hvidovre University Hospital, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 21, 2007

Study Start

January 1, 2007

Study Completion

September 1, 2007

Last Updated

August 21, 2007

Record last verified: 2007-07