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Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade (PAI vs FNB)

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ClinicalTrials.gov Identifier: NCT01335542
Recruitment Status : Completed
First Posted : April 14, 2011
Results First Posted : April 20, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Readiness to Discharge Procedure: Peri-Articular Injection Procedure: Epidural Pathway (PCEA+FNB) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
Study Start Date : March 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Epidural Pathway (PCEA+FNB) 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
Active Comparator: Peri-Articular Injection 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335542


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Jacques T YaDeau, M.D., Ph.D. Hospital for Special Surgery, New York
More Information
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01335542    
Other Study ID Numbers: 10002
First Posted: April 14, 2011    Key Record Dates
Results First Posted: April 20, 2016
Last Update Posted: September 14, 2016
Last Verified: August 2016