Local Infiltration Analgesia Following Total Knee Arthroplasty

Official Title: “Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty”

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Postoperative pain is often severe following knee arthroplasty. Recently, a local infiltration analgesia (LIA) technique was developed by Drs Kerr and Kohan in Sydney, Australia. With this 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. We ahve completed a study on unicompartmental knee arthroplasty and the present study is investigating total knee arthroplasties.

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Intervention(s) in this Clinical Trial

• Drug: ropivacaine, ketorolac and epinephrine
  • In Group A, 400 mg ropivicaine, 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 in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue. After 21 postoperative hours in Group A, 200 mg ropivicaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
• Drug: saline
  • In Group P (placebo) no injections were given intraoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1 Group A(Active)
  • Group A (Active) receives a multimodal injection intra- and postoperatively
• Placebo Comparator: 2 Group P (Placebo)
  • Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively

Primary Measures

• Morphine consumption
  • Time Frame: 0-48 hours
    Safety Issue?: No

Secondary Measures

• hospital stay, pain intensity, side effects, knee function and patient satisfaction scores
  • Time Frame: 0-3 months
    Safety Issue?: No

Inclusion Criteria:

• Patients scheduled for total knee arthroplasty
• Aged 20-85 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University Hospital Orebro Other

Overall Clinical Trial Officials and Contacts

Kjell Axelsson, Prof Principal Investigator University Hospital Orebro, Sweden  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00799175

Study ID Number: RAK-total

ClinicalTrials.gov Identifier: NCT00799175

Health Authority: Sweden: Medical Products Agency