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Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT00968955
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : September 29, 2011
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: Ropivacaine Phase 4

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail
Study Start Date : September 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



Primary Outcome Measures :
  1. Postoperative pain scores on the Visual Analog Scale (during walking) [ Time Frame: up to 8 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968955


Locations
Denmark
Hvidovre University Hospital
Copenhagen, Hvidover, Denmark, 2650
Hørsholm Hospital
Hørsholm, Denmark, 2970
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00968955     History of Changes
Other Study ID Numbers: H-2-2009-079
2009-41-3785
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: September 2011

Keywords provided by Troels Haxholdt Lunn, Hvidovre University Hospital:
Postoperative acute pain
Total hip arthroplasty
Local infiltration analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents