Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Drug: ropivacaine, ketorolac and epinephrine; Drug: morphine

• Registration Number: NCT00992082
• Lead Sponsor: Region Örebro County

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.

Study Timeline

• Study Start: 2009-08
• Status Verified: 2009-10
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Last Update Submitted: 2009-10-08
• Last Update Posted: 2009-10-09
• Primary Completion: 2011-05
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group LIA	ropivacaine, ketorolac and epinephrine	Local Infiltration Analgesia
Group M	morphine	Intrathecal morphine

Primary Outcome Measures

Name	Time	Method
Morphine consumption	The first 48 postoperative hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept. of Orthopedic Surgery; 🇸🇪 Orebro, Sweden