Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty

January 31, 2021 updated by: Brian M. Ilfeld, MD, MS, University of California, San Diego

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Of importance: The primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. In addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. These two groups will not be analyzed together--they represent two distinct studies: one a definitive RCT for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States
        • University of California San Diego Medical Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. morbid obesity as defined by a body mass index >40 (BMI=weight in kg/ [height in meters]
  2. 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)
  3. history of opioid abuse
  4. allergy to study medications
  5. known renal insufficiency (creatinine > 1.5 mg/dL)
  6. pregnancy
  7. incarceration
  8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Femoral perineural local anesthetic infusion
Drug: Control: Femoral perineural local anesthetic infusion
The control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion
EXPERIMENTAL: Experimental
Adductor canal perineural local anesthetic infusion
Drug: Experimental: Adductor Canal perineural local anesthetic infusion
The control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hours Until Discharge Readiness
Time Frame: 7 postoperative days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Adequate Analgesia
Time Frame: First 7 postoperative days
The time in hours until adequate analgesia is defined as pain less than 4 on a Numeric Rating Scale of 0-10, with 0=no pain and 10=worst imaginable pain
First 7 postoperative days
Time Until Independence From Intravenous Analgesics of at Least 12 Hours
Time Frame: First 7 postoperative days
The time in hours until no intravenous analgesics were required for at least 12 hours (without future intravenous use during admission)
First 7 postoperative days
Time Until Timed Up and Go Test Achieved
Time Frame: Hours
The timed-up-and-go (TUG) test measures the ability and speed of standing from a sitting position, walking 3 meters and returning to the original seated position independent from the assistance of healthcare personnel. This variable measured the time in hours until the patient could successfully achieve this test independently, regardless of the amount of time required.
Hours
Time Until Ambulation at Least 30 Meters
Time Frame: 7 postoperative days
The time in hours until a patient could ambulate at least 30 meters independently (regardless of time to achieve the 30 meters)
7 postoperative days
Pain Level
Time Frame: Postoperative Days 1-3
The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Postoperative Days 1-3
Opioid Consumption
Time Frame: Postoperative Days 0-3
Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams
Postoperative Days 0-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Teleflex
Summit Medical Products, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

December 28, 2012

First Posted (ESTIMATE)

January 3, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adductor Canal vs Femoral

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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