Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Registration Number
- NCT00562627
- Lead Sponsor
- Asker & Baerum Hospital
- Brief Summary
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
The aim of this study is to:
1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
- Detailed Description
Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:
1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- patients at least 18 years of age
- scheduled for elective total knee arthroplasty
- ASA I-III
- signed written informed consent
- age < 18
- ASA > III
- moderate or severe cardiac disease, bronchial asthma
- allergy against ropivacaine, ketorolac or morphine
- analgetic abuse
- pregnancy or nursing women
- severe psychiatric disease
- moderate to severe dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LIA IA ketorolac Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine LIA IV ropivacaine Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine LIA IV ketorolac Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine LIA IV morphine Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine LIA IV adrenaline Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine LIA IA ropivacaine Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine LIA IA adrenaline Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine LIA IA morphine Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine EDA adrenaline standard continuous epidural analgesia EDA fentanyl standard continuous epidural analgesia EDA bupivacaine standard continuous epidural analgesia
- Primary Outcome Measures
Name Time Method Pain at Rest (VAS) 48 hours postoperative VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.
- Secondary Outcome Measures
Name Time Method Opioid Use 48 hours postoperative Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.
Time to Readiness for Discharge up to 10 days postoperative Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.
Trial Locations
- Locations (1)
Asker and Baerum Hospital
🇳🇴Rud, Norway