Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Post-operative Pain

Treatments: Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00968955

2009-41-3785

H-2-2009-079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Local infiltration with ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine

Local infiltration with saline

Placebo Comparator group

Description:

Local infiltration with saline (150 ML) (placebo)

Treatment:

Drug: Ropivacaine