Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

September 28, 2011 updated by: Troels Haxholdt Lunn, Hvidovre University Hospital

Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail

The purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty.

The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. The technique is widely used as standard treatment in many European centers despite its limited evidence.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

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

  • Denmark
      • Hørsholm, Denmark, 2970
        • Hørsholm hospital
    • Hvidover
      • Copenhagen, Hvidover, Denmark, 2650
        • Hvidovre University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective total hip arthroplasty
  • Able to speak and understand danish
  • Able to give informed consent

Exclusion Criteria:

  • Alcohol or medical abuse
  • Allergies to local anesthetics
  • Age < 18 years
  • Daily use of opioids or glucocorticoids
  • Pregnancy or breastfeeding
  • Opioid intolerance
  • Obesity defined as BMI>40 kg/m2
  • Diabetic neuropathy and rheumatoid arthritis

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Local infiltration with ropivacaine
Local infiltration with ropivacaine 0,2% (150 ML)
Drug: Ropivacaine
Local infiltration with ropivacaine 0,2% (150 ML)
Placebo Comparator: Local infiltration with saline
Local infiltration with saline (150 ML) (placebo)
Drug: Ropivacaine
Local infiltration with ropivacaine 0,2% (150 ML)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain scores on the Visual Analog Scale (during walking)
Time Frame: up to 8 hours
up to 8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional analgetics measured as cumulated amount i mg
Time Frame: up to 8 hours
up to 8 hours
Time spend in hospital measured as nights after surgery
Time Frame: At discharge (mean 2-3 nights)
At discharge (mean 2-3 nights)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: up to 8 hours
up to 8 hours
Postoperative pain scores on the Visual Analog Scale (at rest)
Time Frame: up to 8 hour
up to 8 hour

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Collaborators

Lundbeck Foundation

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

September 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (Estimate)

August 31, 2009

Study Record Updates

Last Update Posted (Estimate)

September 29, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2009-079
  • 2009-41-3785

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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