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Completed

NCT Number: NCT02121392

Epidural Catheter With or Without Adductor Canal Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty

The purpose of this study is to further investigate the efficacy of adductor canal nerve blocks for pain management after total knee replacement. Specifically we are studying adductor canal nerve blocks in conjunction with epidural anesthesia, which is a combination that has not been extensively researched before. Our question is whether combining these modalities will enhance patient satisfaction after surgery and accelerate patients' readiness to discharge.

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Key information

Age range

Up to 85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

About this study

Knee replacement surgery has become increasingly more common in the United States with hundreds of thousands of surgeries performed yearly across the country. Despite that, there is no consensus "standard of care" for optimum pain control regimen after surgery. Pain management after TKA ranges from local tissue injections and patient controlled anesthesia to regional nerve blocks to neuraxial anesthesia. Although regional anesthesia has become more common and widespread, there are wide variations depending on practice setting (academic versus private), equipment available (adductor nerve blocks require ultrasound guidance), level of training of the anesthesiologists and patient selection, among other factors. Another part of the reason for the wide variations in practice is the lack of literature demonstrating clear effectiveness or superiority of one technique over another.

To date adductor canal nerve blocks have been mainly studied in comparison with femoral nerve blocks in terms of their efficacy in controlling pain and their ability to preserve motor function. Adductor canal nerve blocks have been shown in the literature to be an effective method for postoperative pain control in total knee replacement surgery. One of the unique benefits of this particular technique is that the adductor canal nerve block is primarily a sensory block, thereby controlling pain without impairing motor strength. This is useful for total knee replacement surgery as pain is controlled while quadriceps muscle strength is preserved. With well functioning muscles patients are able to fully participate in physical therapy with less strength impairment and reduced risk of falling.

It is our aim to investigate one multimodal approach that combines the strengths of two proven pain management techniques and thereby improve overall postoperative pain control and patient satisfaction. Our hope is to establish a protocol that is safe and effective for patient care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • end stage degenerative joint disease
  • enrolled for unilateral total knee arthroplasty at the University of Chicago
  • age < 85
  • ability to understand and willingness to sign a written informed consent

Exclusion criteria

  • age > 85
  • American Society of Anesthesiologists physical status > 3
  • known hypersensitivity to lidocaine, bupivacaine, ropivacaine or other local anesthetic agents
  • Coagulopathy, specifically INR > 1.5, Platelets < 100, therapy with clopidogrel within 5 days prior to surgery, enoxaparin or fondaparinux within the last 24 hours prior to surgery, patients with anti-phospholipid syndrome requiring aggressive anticoagulation perioperatively
  • History of alcohol or substance abuse (including strong opioids - morphine, oxycodone, methadone, fentanyl, ketobemidone), taking > 50 mg morphine equivalent daily of opioids
  • Pre-existing femoral neuropathy or radiculopathy
  • Patients with poor ability to communicate

Treatment and study plan

Adductor Canal Nerve Block Catheter

Device

ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The functional ACNB pumps will run 8cc/h.

Adductor Canal Nerve Block Sham Catheter

Device

Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.

Bupivacaine

Drug

In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.

Primary outcomes

  1. Morphine Equivalents

    Time frame: 12 hours postoperatively and 20 hours after placement of catheter

Secondary outcomes

  1. Visual Analog Score for Pain

    Time frame: 12 hours postoperatively and 20 hours after placement of catheter

    The visual analog scale (VAS) is a pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single mark placed at one point along the length of a line that represents a continuum between the two ends of the scale-"no pain" on the left end of the scale (equal to a score of 0) and the "worst pain" on the right end of the scale (equal to a score of 100).

  2. Physical Therapy Ambulation Distance

    Time frame: Daily on postoperative days one and two

  3. Number of Hospital Days Until Discharge Criteria Are Met

    Time frame: within first 3 days (plus or minus 3 days) after surgery

  4. Number of Participants With Bleeding Complications at Adductor Canal Nerve Block Catheter Site

    Time frame: within first 3 days (plus or minus 3 days) after surgery

  5. Number of Participants With Adverse Events Related to Adductor Canal Nerve Block Catheter

    Time frame: within first 3 days (plus or minus 3 days) after surgery

  6. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 3 and 6 weeks

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical function (17 items). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales yields a total WOMAC score.

  7. Range of Motion

    Time frame: postoperative day 1 and 2

    Knee range of motion (ROM) was measured (in degrees) during physical therapy.

  8. Range of Motion at 3 and 6 Week Follow up

    Time frame: 3 and 6 weeks

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Continuous Adductor Canal Block With Epidural Analgesia for Total Knee Arthroplasty: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 23, 2014
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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