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Local Infiltration Analgesia Following Total Knee Arthroplasty (RAK-total)

This study has been completed.
Sponsor:
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00799175
First received: November 26, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 26, 2008
November 26, 2008
April 2007
June 2008   (final data collection date for primary outcome measure)
Morphine consumption [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
hospital stay, pain intensity, side effects, knee function and patient satisfaction scores [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Local Infiltration Analgesia Following Total Knee Arthroplasty
Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Postoperative pain is often severe following knee arthroplasty. Recently, a local infiltration analgesia (LIA) technique was developed by Drs Kerr and Kohan in Sydney, Australia. With this 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. We ahve completed a study on unicompartmental knee arthroplasty and the present study is investigating total knee arthroplasties.

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed 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, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: ropivacaine, ketorolac and epinephrine
    In Group A, 400 mg ropivicaine, 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 in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue. After 21 postoperative hours in Group A, 200 mg ropivicaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
  • Drug: saline
    In Group P (placebo) no injections were given intraoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.
  • Active Comparator: 1 Group A(Active)
    Group A (Active) receives a multimodal injection intra- and postoperatively
    Intervention: Drug: ropivacaine, ketorolac and epinephrine
  • Placebo Comparator: 2 Group P (Placebo)
    Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for total knee arthroplasty
  • Aged 20-85 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
Female
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00799175
RAK-total
Yes
Kjell Axelsson, Prof, University Hospital Orebro, Orebro, Sweden
University Hospital Orebro
Not Provided
Principal Investigator: Kjell Axelsson, Prof University Hospital Orebro, Sweden
University Hospital Orebro
November 2008

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