Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail
Overview
- Phase
- Phase 4
- Intervention
- Ropivacaine
- Conditions
- Post-operative Pain
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Postoperative pain scores on the Visual Analog Scale (during walking)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
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.
Investigators
Troels Haxholdt Lunn
MD
Hvidovre University Hospital
Eligibility 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
Arms & Interventions
Local infiltration with ropivacaine
Local infiltration with ropivacaine 0,2% (150 ML)
Intervention: Ropivacaine
Local infiltration with saline
Local infiltration with saline (150 ML) (placebo)
Intervention: Ropivacaine
Outcomes
Primary Outcomes
Postoperative pain scores on the Visual Analog Scale (during walking)
Time Frame: up to 8 hours
Secondary Outcomes
- 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)