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Completed

NCT Number: NCT00968955

Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

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.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital, Copenhagen, Hvidover, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Local infiltration with ropivacaine 0,2% (150 ML)

Primary outcomes

  1. Postoperative pain scores on the Visual Analog Scale (during walking)

    Time frame: up to 8 hours

Secondary outcomes

  1. Additional analgetics measured as cumulated amount i mg

    Time frame: up to 8 hours

  2. Time spend in hospital measured as nights after surgery

    Time frame: At discharge (mean 2-3 nights)

  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: up to 8 hours

  4. Postoperative pain scores on the Visual Analog Scale (at rest)

    Time frame: up to 8 hour

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 31, 2009
Registry last updated
Sep 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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