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Clinical Trials/NCT00992082
NCT00992082
Unknown
N/A

Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

Region Örebro County1 site in 1 country50 target enrollmentAugust 2009

Overview

Phase
N/A
Intervention
ropivacaine, ketorolac and epinephrine
Conditions
Osteoarthritis
Sponsor
Region Örebro County
Enrollment
50
Locations
1
Primary Endpoint
Morphine consumption
Last Updated
16 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
August 2011
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Region Örebro County

Eligibility Criteria

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.

Arms & Interventions

Group LIA

Local Infiltration Analgesia

Intervention: ropivacaine, ketorolac and epinephrine

Group M

Intrathecal morphine

Intervention: morphine

Outcomes

Primary Outcomes

Morphine consumption

Time Frame: The first 48 postoperative hours

Secondary Outcomes

  • 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)

Study Sites (1)

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