Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of California, San Diego
Sponsor:
Collaborator:
Summit Medical
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01759277
First received: December 21, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. There are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. Both have been demonstrated to be effective following knee arthroplasty. However, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique.

While femoral CPNB has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis. This block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion.

The investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.


Condition Intervention Phase
Postoperative Pain Following Knee Arthroplasty
Drug: Active comparator: Control: Femoral perineural local anesthetic infusion
Drug: Experimental: Adductor Canal perineural local anesthetic infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Discharge readiness [ Time Frame: evaluated every 8 hours until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Discharge readiness is defined as meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.


Secondary Outcome Measures:
  • Time to adequate analgesia [ Time Frame: evaluated until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Adequate analgesia is defined as pain less than 4 on a NRS scale of 0-10.

  • Independence from IV analgesics [ Time Frame: evaluated until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Independence from intravenous opioids for at least 12 hours.

  • TUG [ Time Frame: evaluated twice daily until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    The timed-up-and-go (TUG) test measures the ability and speed of standing from a sitting position, walking 3 meters and returning to the original seated position independent from the assistance of healthcare personnel.

  • 30 meter walk [ Time Frame: evaluated twice daily until discharge (at least 72 hours) ] [ Designated as safety issue: No ]
    This test measures the ability to ambulate 30 meters independent from the assistance of healthcare personnel.

  • Pain scores [ Time Frame: evaluated until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Pain scores will be measured on a NRS of 0-10.

  • Supplemental opioid consumption [ Time Frame: evaluated until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
  • Standing [ Time Frame: evaluated twice daily until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Attaining a standing position without assistance from healthcare personnel.

  • Ambulation distance [ Time Frame: evaluated twice daily until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Ambulation distance without assistance from healthcare personnel.

  • Passive knee flexion [ Time Frame: evaluated twice daily until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Degrees of passive knee flexion as measured by a goniometer.

  • Passive knee extension [ Time Frame: evaluated twice daily until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Degrees of passive knee extension as measured by a goniometer.

  • Average pain score during physical therapy sessions [ Time Frame: evaluated twice daily until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Pain score on NRS scale 0-10.

  • Worst pain score during physical therapy session [ Time Frame: evaluated twice daily until discharge (and at least 72 hours) ] [ Designated as safety issue: No ]
    Pain score on NRS scale 0-10.


Other Outcome Measures:
  • Scanning time [ Time Frame: during catheter placement ] [ Designated as safety issue: No ]
    Time taken to ultrasound appropriate location from time transducer placed until Tuohy needle first inserted.

  • Worst pain during catheter placement [ Time Frame: during catheter placement ] [ Designated as safety issue: No ]
    Pain score on NRS scale 0-10.

  • Catheter insertion time [ Time Frame: Catheter placement ] [ Designated as safety issue: No ]
    Time from Tuohy needle first in until Tuohy needle removed for the final time.


Estimated Enrollment: 150
Study Start Date: December 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Femoral perineural local anesthetic infusion
Drug: Active comparator: Control: Femoral perineural local anesthetic infusion
The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Experimental: Experimental
Adductor canal perineural local anesthetic infusion
Drug: Experimental: Adductor Canal perineural local anesthetic infusion
The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.

Detailed Description:

Of importance: The primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. In addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. These two groups will not be analyzed together--they represent two distinct studies: one a definitive RCT for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. primary, unilateral knee arthroplasty
  2. age ≥ 18 years
  3. postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours

Exclusion Criteria:

  1. morbid obesity as defined by a body mass index >40 (BMI=weight in kg/ [height in meters]
  2. chronic, high-dose opioid use (greater than 20mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use >4 weeks)
  3. history of opioid abuse
  4. allergy to study medications
  5. known renal insufficiency (creatinine > 1.5 mg/dL)
  6. pregnancy
  7. incarceration
  8. any known neuro-muscular deficit of the ipsilateral femoral nerve, obturator nerve and/or quadriceps muscle (including diabetic peripheral neuropathy); and inability to ambulate 30 m preoperatively.
  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: NCT01759277

Locations
United States, California
University of California San Diego Medical Centers Recruiting
San Diego, California, United States
Contact: Brian M Ilfeld, MD, MS    858-657-7072    bilfeld@ucsd.edu   
Principal Investigator: Brial Ilfeld, M.D., M.S.         
Sponsors and Collaborators
University of California, San Diego
Summit Medical
  More Information

Publications:

Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01759277     History of Changes
Other Study ID Numbers: Adductor Canal vs Femoral
Study First Received: December 21, 2012
Last Updated: July 10, 2014
Health Authority: UCSD Human Research Protections Program, United States:

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014