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

Not Applicable

Completed

Conditions: Arthroplasty, Replacement, Knee
Nerve Block

Interventions: Device: Adductor Canal Nerve Block Sham Catheter
Device: Adductor Canal Nerve Block Catheter
Drug: Bupivacaine

Registration Number: NCT02121392

Lead Sponsor: University of Chicago

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 165

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Catheter without Adductor Canal Nerve Block Catheter	Adductor Canal Nerve Block Sham Catheter	Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Epidural Catheter with Adductor Canal Nerve Block Catheter	Adductor Canal Nerve Block Catheter	Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Epidural Catheter without Adductor Canal Nerve Block Catheter	Bupivacaine	Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Epidural Catheter with Adductor Canal Nerve Block Catheter	Bupivacaine	Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.

Primary Outcome Measures

Name	Time	Method
Morphine Equivalents	12 hours postoperatively and 20 hours after placement of catheter

Secondary Outcome Measures

Name	Time	Method
Visual Analog Score for Pain	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).
Physical Therapy Ambulation Distance	Daily on postoperative days one and two
Number of Hospital Days Until Discharge Criteria Are Met	within first 3 days (plus or minus 3 days) after surgery
Number of Participants With Adverse Events Related to Adductor Canal Nerve Block Catheter	within first 3 days (plus or minus 3 days) after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.
Range of Motion	postoperative day 1 and 2	Knee range of motion (ROM) was measured (in degrees) during physical therapy.
Range of Motion at 3 and 6 Week Follow up	3 and 6 weeks
Number of Participants With Bleeding Complications at Adductor Canal Nerve Block Catheter Site	within first 3 days (plus or minus 3 days) after surgery