N/A
N=160
Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)
Osteoarthritis,Knee
Bottom Line
View on ClinicalTrials.gov: NCT01042093 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Numerical Rating Scale (NRS) Pain Scores During Hospitalization. — 1.06; 1.90; 2.67; 1.60 scores on a scale 0-10
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ropivacaine (Drug); Toradol (Drug); Clonidine (Drug); Epinephrine (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Towson Orthopaedic Associates
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numerical Rating Scale (NRS) Pain Scores During Hospitalization. |
1.06; 1.90; 2.67; 1.60; 1.52; 1.52 | — |
| SECONDARY Narcotic Consumption During Hospitalization |
46.92; 43.09; 55.20; 52.50; 46.54; 47.95 | — |
| SECONDARY Knee Society Pain Scores at 6 Week Follow-up Appointment |
45; 43; 45; 45 | — |
Summary
The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery.
The study will compare the level of pain management, length of hospital stay, range of motion and side effects from subjects receiving one of four different combinations of medication in a periarticular injection. The medications used in the injections are approved medications routinely used for pain management.
Approximately 160 subjects will participate in this study. The surgeon, study personnel, and patients will be blinded to the combination of medications each patient receives. The pharmacist will prepare the 4 different combinations of medications, randomize each patient to the particular combination of medications, and maintain the study drug documentation.
Eligibility Criteria
Inclusion Criteria
- Men and Women aged 30 to 85 years
- Voluntary, written informed consent given to participate in this clinical investigation
Exclusion Criteria
- Pregnant or lactating women
- Presence of allergies or contraindication to any medications indicated in the study
- Contraindication to or failure of spinal anesthesia
- Known drug or alcohol abuse or psychologic disorder that could affect follow-up care or treatment outcomes
- Patients with a diagnosis of inflammatory arthritis
- Previous major bone surgery in the operative knee
- Simultaneous, bilateral TKRs
Data sourced from ClinicalTrials.gov (NCT01042093). 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.