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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01335542
First received: April 8, 2011
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Readiness to Discharge
Procedure: Peri-Articular Injection
Procedure: Epidural Pathway (PCEA+FNB)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome 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 ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Pain scores (NRS) [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Pain scores (NRS), both at rest and with therapy during the first 3 postoperative days

  • Conversion to PCA [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Conversion to PCA

  • Referral to the Recuperative Pain Medicine (RPM) service [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Referral to the Recuperative Pain Medicine (RPM) service

  • Patient Satisfaction [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Patient Satisfaction, day 1 and day 3

  • Opioid Related Symptom Distress Scale [ Time Frame: 2nd postoperative day ] [ Designated as safety issue: No ]
    Opioid Related Symptom Distress Scale, postoperative day 2

  • QOR-40 [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Quality of Recovery 40 scores (QOR-40), postoperative day 1 and day 3

  • Opioid Usage [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Opioid Usage

  • Short Form-8 [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Short Form-8 Health Survey is a validated scale measuring patient recovery in terms of patient-reported overall health, physical activity level, difficulty doing daily work, bodily pain levels, etc.

  • LANSS Pain Scale [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs.


Enrollment: 91
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335542

Locations
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
Principal Investigator: Jacques T YaDeau, M.D., Ph.D. Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01335542     History of Changes
Other Study ID Numbers: 10002
Study First Received: April 8, 2011
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014