Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2010

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.

Interventions

  • Drug: Ropivacaine
    • Local infiltration with ropivacaine 0,2% (150 ML)

Arms, Groups and Cohorts

  • Active Comparator: Local infiltration with ropivacaine
    • Local infiltration with ropivacaine 0,2% (150 ML)
  • Placebo Comparator: Local infiltration with saline
    • Local infiltration with saline (150 ML) (placebo)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Additional analgetics measured as cumulated amount i mg
    • Time Frame: up to 8 hours
  • Time spend in hospital measured as nights after surgery
    • Time Frame: 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
  • Postoperative pain scores on the Visual Analog Scale (at rest)
    • Time Frame: up to 8 hour

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hvidovre University Hospital
  • Collaborator
    • Lundbeck Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Troels Haxholdt Lunn, MD – Hvidovre University Hospital

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