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Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty

Primary Purpose

Postoperative Pain Following Knee Arthroplasty

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Control: Femoral perineural local anesthetic infusion
Experimental: Adductor Canal perineural local anesthetic infusion
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain Following Knee Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San Diego Medical Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Femoral perineural local anesthetic infusion

Adductor canal perineural local anesthetic infusion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Adequate Analgesia
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
Time Until Independence From Intravenous Analgesics of at Least 12 Hours
The time in hours until no intravenous analgesics were required for at least 12 hours (without future intravenous use during admission)
Time Until Timed Up and Go Test Achieved
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.
Time Until Ambulation at Least 30 Meters
The time in hours until a patient could ambulate at least 30 meters independently (regardless of time to achieve the 30 meters)
Pain Level
The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Opioid Consumption
Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams

Full Information

First Posted
December 21, 2012
Last Updated
January 31, 2021
Sponsor
University of California, San Diego
Collaborators
Summit Medical Products, Inc., Teleflex
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1. Study Identification

Unique Protocol Identification Number
NCT01759277
Brief Title
Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty
Official Title
Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Summit Medical Products, Inc., Teleflex

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Following Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Femoral perineural local anesthetic infusion
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Adductor canal perineural local anesthetic infusion
Intervention Type
Drug
Intervention Name(s)
Control: Femoral perineural local anesthetic infusion
Intervention Description
The control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion
Intervention Type
Drug
Intervention Name(s)
Experimental: Adductor Canal perineural local anesthetic infusion
Intervention Description
The control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion
Primary Outcome Measure Information:
Title
Hours Until Discharge Readiness
Description
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.
Time Frame
7 postoperative days
Secondary Outcome Measure Information:
Title
Time to Adequate Analgesia
Description
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
Time Frame
First 7 postoperative days
Title
Time Until Independence From Intravenous Analgesics of at Least 12 Hours
Description
The time in hours until no intravenous analgesics were required for at least 12 hours (without future intravenous use during admission)
Time Frame
First 7 postoperative days
Title
Time Until Timed Up and Go Test Achieved
Description
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.
Time Frame
Hours
Title
Time Until Ambulation at Least 30 Meters
Description
The time in hours until a patient could ambulate at least 30 meters independently (regardless of time to achieve the 30 meters)
Time Frame
7 postoperative days
Title
Pain Level
Description
The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Time Frame
Postoperative Days 1-3
Title
Opioid Consumption
Description
Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams
Time Frame
Postoperative Days 0-3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary, unilateral knee arthroplasty age ≥ 18 years postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Ilfeld, MD, MS
Organizational Affiliation
University California San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego Medical Centers
City
San Diego
State/Province
California
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9661552
Citation
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.
Results Reference
background
PubMed Identifier
22221014
Citation
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.
Results Reference
background
PubMed Identifier
22745116
Citation
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.
Results Reference
background
PubMed Identifier
19916251
Citation
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.
Results Reference
background
PubMed Identifier
19901788
Citation
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.
Results Reference
background
PubMed Identifier
22834681
Citation
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.
Results Reference
background
PubMed Identifier
21039357
Citation
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.
Results Reference
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Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty

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