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Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Region Örebro County.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992082
First Posted: October 8, 2009
Last Update Posted: October 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Region Örebro County
  Purpose
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.

Condition Intervention
Osteoarthritis Drug: ropivacaine, ketorolac and epinephrine Drug: morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Region Örebro County:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: The first 48 postoperative hours ]

Secondary Outcome Measures:
  • Pain intensity [ Time Frame: 0-3 months ]
  • Knee function [ Time Frame: 0-3 months ]
  • Time to home readiness [ Time Frame: 0-2 weeks ]
  • Hospital stay [ Time Frame: 0-2 weeks ]
  • Side effects [ Time Frame: 0-3 months ]
  • Patient satisfaction [ Time Frame: 0-3 months ]

Estimated Enrollment: 50
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992082


Contacts
Contact: Per Essving, MD +4619602100 per.essving@orebroll.se
Contact: Kjell Axelsson, Professor +4619602100 kjell.axelsson@orebroll.se

Locations
Sweden
Dept. of Orthopedic Surgery Recruiting
Orebro, Sweden, SE-70185
Contact: Per Essving, MD    +4619602100    per.essving@orebroll.se   
Contact: Kjell Axelsson, Professor    +4619602100    kjell.axelsson@orebroll.se   
Principal Investigator: Kjell Axelsson, Professor         
Sponsors and Collaborators
Region Örebro County
  More Information

Responsible Party: Professor Kjell Axelsson, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT00992082     History of Changes
Other Study ID Numbers: RAK-Spinal
First Submitted: October 7, 2009
First Posted: October 8, 2009
Last Update Posted: October 9, 2009
Last Verified: October 2009

Keywords provided by Region Örebro County:
Postoperative pain
Local Infiltration Analgesia
Knee arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Morphine
Ketorolac
Ketorolac Tromethamine
Ropivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents