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

NCT02121392 | Completed Results

• 1 other identifier: IRB13-1438
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee; Nerve Block

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalents

  12 hours postoperatively and 20 hours after placement of catheter

Secondary Outcomes (8)

• 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 Bleeding Complications at Adductor Canal Nerve Block Catheter Site

  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

Study Arms (2)

Epidural Catheter without Adductor Canal Nerve Block Catheter

SHAM COMPARATOR

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.

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

Epidural Catheter with Adductor Canal Nerve Block Catheter

EXPERIMENTAL

Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.

Device: Adductor Canal Nerve Block Catheter; Drug: Bupivacaine

Interventions

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.

Epidural Catheter with Adductor Canal Nerve Block Catheter

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.

Epidural Catheter without Adductor Canal Nerve Block Catheter

Bupivacaine 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; Epidural Catheter without Adductor Canal Nerve Block Catheter

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (11)

• Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.

  PMID: 24121608 BACKGROUND

• 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.

  PMID: 24401769 BACKGROUND

• 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.

  PMID: 23788068 BACKGROUND

• Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.

  PMID: 23241723 BACKGROUND

• Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.

  PMID: 24401802 BACKGROUND

• Mudumbai SC, Kim TE, Howard SK, Workman JJ, Giori N, Woolson S, Ganaway T, King R, Mariano ER. Continuous adductor canal blocks are superior to continuous femoral nerve blocks in promoting early ambulation after TKA. Clin Orthop Relat Res. 2014 May;472(5):1377-83. doi: 10.1007/s11999-013-3197-y.

  PMID: 23897505 BACKGROUND

• Henningsen MH, Jaeger P, Hilsted KL, Dahl JB. Prevalence of saphenous nerve injury after adductor-canal-blockade in patients receiving total knee arthroplasty. Acta Anaesthesiol Scand. 2013 Jan;57(1):112-7. doi: 10.1111/j.1399-6576.2012.02792.x. Epub 2012 Oct 17.

  PMID: 23074997 BACKGROUND

• Ishiguro S, Yokochi A, Yoshioka K, Asano N, Deguchi A, Iwasaki Y, Sudo A, Maruyama K. Technical communication: anatomy and clinical implications of ultrasound-guided selective femoral nerve block. Anesth Analg. 2012 Dec;115(6):1467-70. doi: 10.1213/ANE.0b013e31826af956. Epub 2012 Aug 10.

  PMID: 22886842 BACKGROUND

• Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.

  PMID: 22834681 BACKGROUND

• Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.

  PMID: 22221014 BACKGROUND

• 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.

  PMID: 29890381 DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Limitations included the number of patients withdrawn (n = 89) after randomization. The majority withdrew due to unsuccessful epidural catheterization (n = 34). Despite this, these patients were distributed evenly across the two groups.

Results Point of Contact

• Title: Dr. Hue Luu
• Organization: University of Chicago Medical Center

hluu@bsd.uchicago.edu

773-702-6937

Study Officials

• Hue Luu, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Magdalena Anitescu, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• David Dickerson, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 23, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-09

Locations

US (1)