Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative acute pain, Total hip arthroplasty, Local infiltration analgesia