Phase 4
N=90
Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
Readiness to Discharge
Bottom Line
View on ClinicalTrials.gov: NCT01335542 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: The Primary Outcome is Time Until a Patient is "Ready for Discharge." — 3.2; 3.2 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Peri-Articular Injection (Procedure); Epidural Pathway (PCEA+FNB) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome is Time Until a Patient is "Ready for Discharge." |
3.2; 3.2 | — |
Summary
There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a peri-articular injection (injection of pain medication around the knee), pills for pain and a pain patch on the skin. The purpose of this research project is to find out if one of these ways to treat pain is better than the other. The investigators will look at this question in many ways, but the main way is how long it takes for you to be judged ready for discharge from the hospital.
Eligibility Criteria
Inclusion Criteria
- Patients with osteoarthritis scheduled for primary bicompartmental total knee arthroplasty with a participating surgeon
- Age 18 to 85 years old
- Planned use of regional anesthesia
- Ability to follow study protocol
- Up to 15 degrees varus, up to 15 degrees flexion and up to 15 degrees valgus
Exclusion Criteria
- Patients younger than 18 years old and older than 85
- Patients intending to receive general anesthesia
- Allergy or intolerance to one of the study medications
- Patients with an ASA of IV
- Patients with insulin-dependent diabetes
- Patients with hepatic (liver) failure
- Patients with chronic renal (kidney) failure
- Chronic opioid use (taking opioids for longer than 3 months)
- Patients with any prior major ipsilateral open knee surgery.
- Patients with flexion contracture of knee > 15 degrees
- Patients with varus deformity > 15 degrees
- Patients with valgus deformity > 15 degrees
- Patients with a contraindication to use of epinephrine
Data sourced from ClinicalTrials.gov (NCT01335542). 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.