Local Infiltration Analgesia Following Total Knee Arthroplasty (RAK-total)
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|ClinicalTrials.gov Identifier: NCT00799175|
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : November 27, 2008
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: ropivacaine, ketorolac and epinephrine Drug: saline||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||September 2008|
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.
- Morphine consumption [ Time Frame: 0-48 hours ]
- hospital stay, pain intensity, side effects, knee function and patient satisfaction scores [ Time Frame: 0-3 months ]
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): NCT00799175
|University Hospital Orebro|
|Orebro, Sweden, 701 85|
|University Hospital Orebro|
|Orebro, Sweden, 70185|
|Principal Investigator:||Kjell Axelsson, Prof||University Hospital Orebro, Sweden|