Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty

NCT01759277 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Adductor Canal vs Femoral
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. There are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. Both have been demonstrated to be effective following knee arthroplasty. However, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique. While femoral CPNB has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis. This block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion. The investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.

Conditions

Postoperative Pain Following Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Hours Until Discharge Readiness

  Discharge readiness is the number of hours until meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.

  7 postoperative days

Secondary Outcomes (6)

• Time to Adequate Analgesia

  First 7 postoperative days

• Time Until Independence From Intravenous Analgesics of at Least 12 Hours

  First 7 postoperative days

• Time Until Timed Up and Go Test Achieved

  Hours

• Time Until Ambulation at Least 30 Meters

  7 postoperative days

• Pain Level

  Postoperative Days 1-3

Study Arms (2)

Control

ACTIVE COMPARATOR

Femoral perineural local anesthetic infusion

Drug: Control: Femoral perineural local anesthetic infusion

Experimental

EXPERIMENTAL

Adductor canal perineural local anesthetic infusion

Drug: Experimental: Adductor Canal perineural local anesthetic infusion

Interventions

Control: Femoral perineural local anesthetic infusion DRUG

The control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion

Control

Experimental: Adductor Canal perineural local anesthetic infusion DRUG

The control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary, unilateral knee arthroplasty
• age ≥ 18 years
• postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours

You may not qualify if:

• morbid obesity as defined by a body mass index \>40 (BMI=weight in kg/ \[height in meters\]
• chronic, high-dose opioid use (greater than 20mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use \>4 weeks)
• history of opioid abuse
• allergy to study medications
• known renal insufficiency (creatinine \> 1.5 mg/dL)
• pregnancy
• incarceration
• any known neuro-muscular deficit of the ipsilateral femoral nerve, obturator nerve and/or quadriceps muscle (including diabetic peripheral neuropathy); and inability to ambulate 30 m preoperatively.

Sponsors & Collaborators

• University of California, San Diego: lead
• Summit Medical Products, Inc.: collaborator
• Teleflex: collaborator

Study Sites (1)

University of California San Diego Medical Centers

San Diego, California, United States

Location

Related Publications (7)

• Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.

  PMID: 9661552 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

• Ilfeld BM, Loland VJ, Sandhu NS, Suresh PJ, Bishop MJ, Donohue MC, Ferguson EJ, Madison SJ. Continuous femoral nerve blocks: the impact of catheter tip location relative to the femoral nerve (anterior versus posterior) on quadriceps weakness and cutaneous sensory block. Anesth Analg. 2012 Sep;115(3):721-7. doi: 10.1213/ANE.0b013e318261f326. Epub 2012 Jun 28.

  PMID: 22745116 BACKGROUND

• Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.

  PMID: 19916251 BACKGROUND

• Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.

  PMID: 19901788 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

• Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.

  PMID: 21039357 BACKGROUND

Results Point of Contact

• Title: Brian Ilfeld
• Organization: University of California San Diego

bilfeld@ucsd.edu

858-822-2171

Study Officials

• Brian M Ilfeld, MD, MS

  University California San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: January 3, 2013
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 18, 2021
• Results First Posted: February 17, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)