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Clinical Trials/NCT01335542
NCT01335542
Completed
Phase 4

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

Hospital for Special Surgery, New York1 site in 1 country91 target enrollmentMarch 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Readiness to Discharge
Sponsor
Hospital for Special Surgery, New York
Enrollment
91
Locations
1
Primary Endpoint
The Primary Outcome is Time Until a Patient is "Ready for Discharge."
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
September 2011
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital for Special Surgery, New York
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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)

Study Sites (1)

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