Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

Phase 4

Completed

• Conditions: Post-operative Pain
• Interventions: Drug: Ropivacaine

• Registration Number: NCT00968955
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Study Start: 2009-09
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-28
• Last Update Posted: 2011-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local infiltration with ropivacaine	Ropivacaine	Local infiltration with ropivacaine 0,2% (150 ML)
Local infiltration with saline	Ropivacaine	Local infiltration with saline (150 ML) (placebo)

Primary Outcome Measures

Name	Time	Method
Postoperative pain scores on the Visual Analog Scale (during walking)	up to 8 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidover, Denmark

Hørsholm Hospital; 🇩🇰 Hørsholm, Denmark