Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University Hospital Orebro.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00992082
First received: October 7, 2009
Last updated: October 8, 2009
Last verified: October 2009

October 7, 2009
October 8, 2009
August 2009
May 2011   (final data collection date for primary outcome measure)
Morphine consumption [ Time Frame: The first 48 postoperative hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00992082 on ClinicalTrials.gov Archive Site
  • Pain intensity [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
  • Knee function [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
  • Time to home readiness [ Time Frame: 0-2 weeks ] [ Designated as safety issue: No ]
  • Hospital stay [ Time Frame: 0-2 weeks ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]
  • Patient satisfaction [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Osteoarthritis
  • 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.
  • Active Comparator: Group LIA
    Local Infiltration Analgesia
    Intervention: Drug: ropivacaine, ketorolac and epinephrine
  • Active Comparator: Group M
    Intrathecal morphine
    Intervention: Drug: morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years to 85 Years
No
Contact: Per Essving, MD +4619602100 per.essving@orebroll.se
Contact: Kjell Axelsson, Professor +4619602100 kjell.axelsson@orebroll.se
Sweden
 
NCT00992082
RAK-Spinal
Yes
Professor Kjell Axelsson, University Hospital Orebro
University Hospital Orebro
Not Provided
Not Provided
University Hospital Orebro
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP