Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 2011

Interventions

  • Procedure: Peri-Articular Injection
    • Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
  • Procedure: Epidural Pathway (PCEA+FNB)
    • Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV

Arms, Groups and Cohorts

  • Active Comparator: Epidural Pathway (PCEA+FNB)
  • Active Comparator: Peri-Articular Injection

Clinical Trial Outcome Measures

Primary Measures

  • The Primary Outcome is Time Until a Patient is “Ready for Discharge.”
    • Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days
    • The primary outcome is time until a patient is “ready for discharge.” Discharge criteria are: PCA (if present) has been discontinued Not experiencing moderate or severe nausea (within last 4 hours). Solid food diet Able to urinate (Foley catheter removed) Pain: NRS <4. Surgical wound dry No acute medical problems Physical Therapy Criteria Independently transfer from supine to sit, from sitting to standing Ambulate 40 ft. without assistance Extension range of motion (< 10 degrees)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital for Special Surgery, New York
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jacques T YaDeau, M.D., Ph.D., Principal Investigator, Hospital for Special Surgery, New York

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