Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty|
- Morphine consumption [ Time Frame: The first 48 postoperative hours ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Group LIA
Local Infiltration Analgesia
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.
Active Comparator: Group M
Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992082
|Dept. of Orthopedic Surgery|
|Orebro, Sweden, SE-70185|