Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
Information source: Hospital for Special Surgery, New York
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Readiness to Discharge
Intervention: Peri-Articular Injection (Procedure); Epidural Pathway (PCEA+FNB) (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hospital for Special Surgery, New York Official(s) and/or principal investigator(s):
Jacques T YaDeau, M.D., Ph.D., Principal Investigator, Affiliation: Hospital for Special Surgery, New York
Overall contact:
Matthew Rade, B.A., Phone: 212.774.7022, Email: RadeM@hss.edu
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.
Clinical Details
Official title: Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
Primary outcome: The primary outcome is time until a patient is "ready for discharge."
Secondary outcome: Pain scores (NRS)Conversion to PCA Referral to the Recuperative Pain Medicine (RPM) service Patient Satisfaction Opioid Related Symptom Distress Scale QOR-40 Opioid Usage Short Form-8 LANSS Pain Scale
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Matthew Rade, B.A., Phone: 212.774.7022, Email: RadeM@hss.edu
Hospital for Special Surgery, New York, New York 10021, United States; Recruiting
Tzipora Kuba, Ph.D., Phone: 212-774-7154, Email: KubaT@hss.edu
Jacques T YaDeau, M.D., Ph.D., Principal Investigator
Chitranjan Ranawat, M.D., Sub-Investigator
Amar Ranawat, M.D., Sub-Investigator
Michael Alexiades, M.D., Sub-Investigator
Geoffrey Westrich, M.D., Sub-Investigator
Douglas Padgett, M.D., Sub-Investigator
Edwin Su, M.D., Sub-Investigator
David Mayman, M.D., Sub-Investigator
Devan Bhagat, M.D., Sub-Investigator
Enrique Goytizolo, M.D., Sub-Investigator
Kethy Jules-Elysee, M.D., Sub-Investigator
Yi Lin, M.D., Sub-Investigator
Spencer S Liu, M.D., Sub-Investigator
Richard Kahn, M.D., Sub-Investigator
Additional Information
Starting date: March 2010
Last updated: April 13, 2011
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