Official Title

Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    80
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.
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 Started
Dec 31
2012
Primary Completion
Sep 30
2014
Study Completion
Sep 30
2014
Results Posted
Feb 17
2020
Last Update
Feb 18
2021

Drug Control: Femoral perineural local anesthetic infusion

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

Control Active Comparator

Femoral perineural local anesthetic infusion

Experimental Experimental

Adductor canal perineural local anesthetic infusion

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.

Summary

Control

Experimental

All Events

Event Type Organ System Event Term Control Experimental

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.

Control

61.0
hours (Median)
Inter-Quartile Range: 49.0 to 69.0

Experimental

55.0
hours (Median)
Inter-Quartile Range: 42.0 to 63.0

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

Control

61.6
Hours (Mean)
Standard Deviation: 20.2

Experimental

61.0
Hours (Mean)
Standard Deviation: 19.3

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)

Control

46.1
Hours (Mean)
Standard Deviation: 20.1

Experimental

47.5
Hours (Mean)
Standard Deviation: 22.7

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.

Control

33.4
Hours (Mean)
Standard Deviation: 7.0

Experimental

46.8
Hours (Mean)
Standard Deviation: 14.5

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)

Control

40.9
Hours (Mean)
Standard Deviation: 13.0

Experimental

56.6
Hours (Mean)
Standard Deviation: 16.7

Pain Level

The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain

Control

Postoperative Day 1 (08:00-16:00)

4.4
score on a scale (Mean)
Standard Deviation: 2.0

Postoperative Day 2 (08:00-16:00)

3.7
score on a scale (Mean)
Standard Deviation: 1.9

Postoperative Day 3 (00:00-8:00)

2.5
score on a scale (Mean)
Standard Deviation: 2.1

Experimental

Postoperative Day 1 (08:00-16:00)

3.7
score on a scale (Mean)
Standard Deviation: 2.3

Postoperative Day 2 (08:00-16:00)

3.4
score on a scale (Mean)
Standard Deviation: 2.1

Postoperative Day 3 (00:00-8:00)

2.8
score on a scale (Mean)
Standard Deviation: 2.1

Opioid Consumption

Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams

Control

Postoperative Day 0 (day)

0.9
milligrams (Mean)
Standard Deviation: 2.3

Postoperative Day 0 (evening)

7.2
milligrams (Mean)
Standard Deviation: 6.5

Postoperative Day 1 (Day)

11.0
milligrams (Mean)
Standard Deviation: 6.9

Postoperative Day 1 (evening)

8.6
milligrams (Mean)
Standard Deviation: 5.5

Postoperative Day 1 (night)

5.1
milligrams (Mean)
Standard Deviation: 6.7

Postoperative Day 2 (day)

9.6
milligrams (Mean)
Standard Deviation: 6.5

Postoperative Day 2 (evening)

6.5
milligrams (Mean)
Standard Deviation: 5.8

Postoperative Day 2 (night)

4.1
milligrams (Mean)
Standard Deviation: 4.6

Postoperative Day 3 (night

4.9
milligrams (Mean)
Standard Deviation: 6.4

Recovery Room

8.6
milligrams (Mean)
Standard Deviation: 7.6

Experimental

Postoperative Day 0 (day)

1.5
milligrams (Mean)
Standard Deviation: 4.6

Postoperative Day 0 (evening)

8.5
milligrams (Mean)
Standard Deviation: 6.2

Postoperative Day 1 (Day)

12.6
milligrams (Mean)
Standard Deviation: 10.0

Postoperative Day 1 (evening)

10.9
milligrams (Mean)
Standard Deviation: 6.3

Postoperative Day 1 (night)

5.6
milligrams (Mean)
Standard Deviation: 6.5

Postoperative Day 2 (day)

10.2
milligrams (Mean)
Standard Deviation: 6.8

Postoperative Day 2 (evening)

7.2
milligrams (Mean)
Standard Deviation: 6.5

Postoperative Day 2 (night)

5.6
milligrams (Mean)
Standard Deviation: 6.2

Postoperative Day 3 (night

5.1
milligrams (Mean)
Standard Deviation: 5.8

Recovery Room

8.0
milligrams (Mean)
Standard Deviation: 8.5

Total

80
Participants

Age, Continuous

66
years (Mean)
Standard Deviation: 8

Body Mass Index

30
kg/m2 (Mean)
Standard Deviation: 5

Height

169
cm (Mean)
Standard Deviation: 11

Race and Ethnicity Not Collected

0
Participants

Weight

86
kg (Mean)
Standard Deviation: 17

Sex: Female, Male

Overall Study

Control

Experimental