Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter

August 17, 2010 updated by: Spenshult Hospital
Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique implicates that a catheter is left in the surgical area and that local anestesia can be administered post surgery. The goal is no or only little pain with minimal side effects. The catheter could be placed intra- or extracapsulare. The best position is not known. Primary aim is to study if position of the catheter effects the need of other postoperative analgesia. Secondary aim is to study if the position effects patient mobility within the first two days.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing arthroplastic surgery of knee or hip

Exclusion Criteria:

  • Sensitivity to local anesthetics
  • Other reason not to use local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intracapsulare position
Procedure: Position of catheter
Position of catheter for administration of local anestesia.
Active Comparator: Extracapsulare position
Procedure: Position of catheter
Position of catheter for administration of local anestesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need for other postoperative analgesia.
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient mobility within the first 48 hours.
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spenshult Hospital

Investigators

  • Study Chair: Stefan Bergman, MD, PhD, R&D-center Spenshult

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Estimate)

August 18, 2010

Last Update Submitted That Met QC Criteria

August 17, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOUS09002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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