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 Overview

• Status: Unknown
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: ropivacaine, ketorolac and epinephrine; Drug: morphine

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Per Essving, MD; Phone Number: +4619602100; Email: per.essving@orebroll.se
• Study Contact Backup: Name: Kjell Axelsson, Professor; Phone Number: +4619602100; Email: kjell.axelsson@orebroll.se

Study Locations

• Sweden
  • Orebro, Sweden, SE-70185
    • Recruiting
    • Dept. of Orthopedic Surgery
    • Contact: Per Essving, MD; Phone Number: +4619602100; Email: per.essving@orebroll.se
    • Contact: Kjell Axelsson, Professor; Phone Number: +4619602100; Email: kjell.axelsson@orebroll.se
    • Principal Investigator: Kjell Axelsson, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group LIA; Local Infiltration Analgesia	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.
Active Comparator: Group M; Intrathecal morphine	Drug: morphine; Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morphine consumption	The first 48 postoperative hours

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Region Örebro County

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): May 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: October 7, 2009
• First Submitted That Met QC Criteria: October 7, 2009
• First Posted (Estimate): October 8, 2009

Study Record Updates

• Last Update Posted (Estimate): October 9, 2009
• Last Update Submitted That Met QC Criteria: October 8, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Postoperative pain; Knee arthroplasty; Local Infiltration Analgesia
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ketorolac; Ropivacaine; Morphine; Epinephrine
• Other Study ID Numbers: RAK-Spinal