Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to determine whether local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty.

Detailed Description
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Postoperative pain is often severe following total knee arthroplasty. Spinal anesthesia is a common method in total knee arthroplasty. Adding morphine to the local anesthetic injected intrathecally prolongs the analgetic effect, but may give the usual opioid side effects. The Local Infiltration Analgesia (LIA) technique has proven effective in reducing postoperative pain in total knee arthroplasty. In the LIA technique a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively. The aim of this study is to evaluate if spinal anesthesia together with the LIA technique provide better postoperative pain relief and mobilization than spinal anesthesia with addition of morphine to the local anesthetic intrathecally. Primary end-point is morphine consumption the first 48 postoperative hours. Secondary end-points are pain intensity, knee function, time to home readiness, hospital stay, side effects and patient satisfaction. Patients are followed up to 3 months after surgery.

Official Title
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Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: ropivacaine, ketorolac and epinephrine
* Drug: morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for total knee arthroplasty under spinal anesthesia. Aged 40-85 yrs. ASA physical status I-III and mobility indicating normal postoperative mobilization. Exclusion Criteria: Known allergy or intolerance to one of the study drugs. Serious liver-, heart- or renal decease. Rheumatoid arthritis. Chronic pain or bleeding disorder.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group LIA<br>Local Infiltration Analgesia | Drug: ropivacaine, ketorolac and epinephrine<br>* Spinal injection: bupivacaine 17.5 mg (3,5 mL) + 0.25 mL 0.9% saline. Local Infiltration Analgesia: 400 mg ropivacaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation. On the first and on the second postoperative morning, 200 mg ropivacaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.<br>|
| Active Comparator: Group M<br>Intrathecal morphine | Drug: morphine<br>* Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption |  | The first 48 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity |  | 0-3 months | 
| Knee function |  | 0-3 months | 
| Time to home readiness |  | 0-2 weeks | 
| Hospital stay |  | 0-2 weeks | 
| Side effects |  | 0-3 months | 
| Patient satisfaction |  | 0-3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Local Infiltration Analgesia, Knee arthroplasty