Local Infiltration Analgesia Following Total Knee Arthroplasty (RAK-total)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty|
- Morphine consumption [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
- hospital stay, pain intensity, side effects, knee function and patient satisfaction scores [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1 Group A(Active)
Group A (Active) receives a multimodal injection intra- and postoperatively
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.
Placebo Comparator: 2 Group P (Placebo)
Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799175
|University Hospital Orebro|
|Orebro, Sweden, 701 85|
|University Hospital Orebro|
|Orebro, Sweden, 70185|
|Principal Investigator:||Kjell Axelsson, Prof||University Hospital Orebro, Sweden|