Phase 4
N=101
Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT00901628 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Pain( Visual Analog Scale ) — 2.3; 6.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ropivacaine (Drug); morphine sulfate (Drug); ketorolac (Drug); epinephrine (Drug); cefuroxime (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain( Visual Analog Scale ) |
2.3; 6.4 | — |
| SECONDARY Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery |
169.4; 262.3 | — |
| SECONDARY Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery |
22; 15 | — |
| SECONDARY the Proportion of Patients Who Were Satisfied With the Pain Management |
38; 39 | — |
| SECONDARY The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended |
18; 6 | — |
| SECONDARY Maximal Flexion Angle Degree on Postoperative 7 Day |
92.3; 95.2 | — |
Summary
The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary osteoarthritis
- Scheduled for elective total knee arthroplasty
- Signed written informed consent
- Spinal anesthesia
Exclusion Criteria
- Patients refusing consents
- inability to use the outcome assessment tools
- Contraindications to regional anesthesia
- severe cardiovascular disease
- allergy or contraindication to drugs used in this study
- pre-existing neurologic disease including psychiatric disorder
- drug abuser
Data sourced from ClinicalTrials.gov (NCT00901628). 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.