Phase 4
N=102
Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT00562627 ↗Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Aug 2011
Primary outcome: Primary: Pain at Rest (VAS) — 18; 12; 30 Units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ropivacaine (Drug); adrenaline (Drug); ketorolac (Drug); morphine (Drug); fentanyl (Drug); bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asker & Baerum Hospital
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain at Rest (VAS) |
18; 12; 30 | 0.001 sig |
| SECONDARY Opioid Use |
77; 49; 54 | 0.009 sig |
| SECONDARY Time to Readiness for Discharge |
4; 3.5; 5.5 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- patients at least 18 years of age
- scheduled for elective total knee arthroplasty
- ASA I-III
- signed written informed consent
Exclusion Criteria
- age 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
Data sourced from ClinicalTrials.gov (NCT00562627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.