Local Infiltration Analgesia Following Unicompartmental Knee Arthroplasty
|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 (LIA) With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Unicompartmental Knee Arthroplasty|
- The primary aim of this study was to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. [ Time Frame: April, 2007 ] [ Designated as safety issue: No ]
- Secondary end-points were morphine consumption, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores were assessed up to 6 months after surgery. [ Time Frame: September, 2007 ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2005|
|Study Completion Date:||September 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Active Comparator: A
Group A (Active) receives a multimodal injection intra- and postoperatively
Drug: ropivacaine, ketorelac and epinephrine
In Group A, 200 mg ropivicaine, 30 mg ketorelac and 0.5 mg epinephrine (total volume 106 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, 150 mg ropivicaine, 30 mg ketorelac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
Placebo Comparator: P
Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively
In Group P (placebo) no injections were given intaoperatively. 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.
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 hospital stay. Secondary end-points were morphine consumption, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores were assessed up to 6 months after surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653926
|Dept. of Orthopedic Surgery and Anesthesia and Intensive Care|
|Orebro, Sweden, SE-70185|
|Principal Investigator:||Kjell Axelsson, Prof.||Orebro University Hospital, Orebro, Sweden|