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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2011

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.

Intervention(s) in this Clinical Trial

• Drug: ropivacaine, ketorolac and epinephrine
  • 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.
• Drug: morphine
  • Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Group LIA
  • Local Infiltration Analgesia
• Active Comparator: Group M
  • Intrathecal morphine

Primary Measures

• Morphine consumption
  • Time Frame: The first 48 postoperative hours
    Safety Issue?: No

Secondary Measures

• Pain intensity
  • Time Frame: 0-3 months
    Safety Issue?: No
• Knee function
  • Time Frame: 0-3 months
    Safety Issue?: No
• Time to home readiness
  • Time Frame: 0-2 weeks
    Safety Issue?: No
• Hospital stay
  • Time Frame: 0-2 weeks
    Safety Issue?: No
• Side effects
  • Time Frame: 0-3 months
    Safety Issue?: Yes
• Patient satisfaction
  • Time Frame: 0-3 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital Orebro

Overall Clinical Trial Officials and Contacts

Overall Contact: Per Essving, MD +4619602100 per.essving@orebroll.se

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00992082

Study ID Number: RAK-Spinal

ClinicalTrials.gov Identifier: NCT00992082

Health Authority: Sweden: Medical Products Agency