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Clinical Trials/NCT02121392
NCT02121392
Completed
Not Applicable

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

University of Chicago1 site in 1 country165 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Adductor Canal Nerve Block Sham Catheter
Conditions
Arthroplasty, Replacement, Knee
Sponsor
University of Chicago
Enrollment
165
Locations
1
Primary Endpoint
Morphine Equivalents
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
January 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Epidural Catheter without Adductor Canal Nerve Block 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.

Intervention: Adductor Canal Nerve Block Sham Catheter

Epidural Catheter without Adductor Canal Nerve Block 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.

Intervention: Bupivacaine

Epidural Catheter with 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.

Intervention: Adductor Canal Nerve Block Catheter

Epidural Catheter with 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.

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Morphine Equivalents

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

Secondary Outcomes

  • Visual Analog Score for Pain(12 hours postoperatively and 20 hours after placement of catheter)
  • 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)
  • Range of Motion(postoperative day 1 and 2)
  • 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)

Study Sites (1)

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