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

NCT ID: NCT02121392

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-01-31

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.

Conditions

Arthroplasty, Replacement, Knee; Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Adductor Canal Nerve Block Sham Catheter

Intervention Type: 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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Adductor Canal Nerve Block Catheter

Intervention Type: 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.

Bupivacaine

Intervention Type: DRUG

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

Interventions

Adductor Canal Nerve Block Catheter

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.

Intervention Type: DEVICE

Adductor Canal Nerve Block Sham Catheter

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.

Intervention Type: DEVICE

Bupivacaine

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

Intervention Type: DRUG

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

• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hue Luu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Magdalena Anitescu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

David Dickerson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medicine

Chicago, Illinois, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 24121608 (View on PubMed)

Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

Reference Type: BACKGROUND

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Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.

Reference Type: BACKGROUND

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Leung P, Dickerson DM, Denduluri SK, Mohammed MK, Lu M, Anitescu M, Luu HH. Postoperative continuous adductor canal block for total knee arthroplasty improves pain and functional recovery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:46-52. doi: 10.1016/j.jclinane.2018.06.004. Epub 2018 Jun 8.

Reference Type: DERIVED

PMID: 29890381 (View on PubMed)

Other Identifiers

IRB13-1438

Identifier Type: -

Identifier Source: org_study_id