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Total Knee Arthroplasty Utilizing Adductor Canal Block: Effect on Quadriceps Sparing

Primary Purpose

Osteoarthritis (Knee)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Volume Adductor Canal Block
Low Volume Adductor Canal Block
Femoral Nerve Block
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis (Knee) focused on measuring adductor canal, femoral, quadriceps

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients undergoing primary unilateral total knee arthroplasty
  • Planned use of combined spinal epidural (CSE) anesthesia
  • Ability to follow study protocol

Exclusion Criteria:

  • Contraindication to a spinal or epidural anesthetic
  • Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
  • Allergy to local anesthetics
  • Pre-existing neuropathy or weakness of the operative limb
  • Any neuromuscular disorder
  • Diabetes type I and II
  • Contraindication to a femoral nerve block or adductor canal nerve block
  • Allergy or intolerance to any of the study medications
  • BMI > 35 kg/m2

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

High volume Adductor canal block

Low volume Adductor Canal Block

Femoral nerve block

Arm Description

Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine

Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine

Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine

Outcomes

Primary Outcome Measures

Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve
After CSE effect, but prior to peripheral block, quadriceps function will be assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve by placing an ECG electrode over the femoral location (determined by U/S) in the inguinal groove. The threshold amperage that produces patellar motion in response to electrical stimulation will be recorded. This threshold amperage will serve as a baseline value. Following the peripheral nerve block, transcutaneous stimulation will be repeated and, if still possible to elicit quadriceps contractions in response to electrical stimulation, the resulting new threshold amperage will be measured. The new threshold amperage will be expressed as a percentage of the baseline value and serve as a quantitative functional indication of the extent of quadriceps paresis resulting from the peripheral nerve block. The primary outcome will be quadriceps paralysis - yes/no.

Secondary Outcome Measures

Threshold amperage as a percentage of the baseline value
Following the peripheral nerve block, transcutaneous stimulation will be repeated and, if still possible to elicit quadriceps contractions in response to electrical stimulation, the resulting new threshold amperage will be measured. The new threshold amperage will be expressed as a percentage of the baseline value and serve as a quantitative functional indication of the extent of quadriceps paresis resulting from the peripheral nerve block.
Analgesic adequacy
Analgesic adequacy as determined by pain scores (0-10) at spinal resolution (on average 2 hours post-op), 24 hours post-op and 48 hours post-op and daily epidural patient controlled analgesia consumption
Ability to complete a straight leg lift
Ability to complete and hold (for 3 seconds) a straight leg lift (from supine position) against gravity as evidence of meaningful quadriceps function - performed in holding area (baseline), at spinal resolution (on average 2 hours post-op), 24 hours post-op and 48 hours post-op

Full Information

First Posted
February 28, 2014
Last Updated
January 29, 2016
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT02081911
Brief Title
Total Knee Arthroplasty Utilizing Adductor Canal Block: Effect on Quadriceps Sparing
Official Title
Postoperative Pain Management Following Total Knee Arthroplasty Utilizing Adductor Canal Block: Effects on Pain Management and Quadriceps Sparing
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate whether there is quantitative motor-sparing of the quadriceps muscles following adductor canal nerve block versus femoral nerve block. Patients will be randomly placed into one of three treatment groups: 1) Femoral nerve block, 2) Adductor canal nerve block - low volume, or 3) Adductor canal nerve block - high volume. Quadriceps function will be assessed in the operating room using a skin patch and electrical stimulation. Follow up visits with the patients will continue over the course of 2 days during patient's stay at the hospital. A total of 60 patients will be enrolled for the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis (Knee)
Keywords
adductor canal, femoral, quadriceps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High volume Adductor canal block
Arm Type
Experimental
Arm Description
Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine
Arm Title
Low volume Adductor Canal Block
Arm Type
Experimental
Arm Description
Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine
Arm Title
Femoral nerve block
Arm Type
Experimental
Arm Description
Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine
Intervention Type
Procedure
Intervention Name(s)
High Volume Adductor Canal Block
Intervention Description
Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine
Intervention Type
Procedure
Intervention Name(s)
Low Volume Adductor Canal Block
Intervention Description
Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve Block
Intervention Description
Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine
Primary Outcome Measure Information:
Title
Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve
Description
After CSE effect, but prior to peripheral block, quadriceps function will be assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve by placing an ECG electrode over the femoral location (determined by U/S) in the inguinal groove. The threshold amperage that produces patellar motion in response to electrical stimulation will be recorded. This threshold amperage will serve as a baseline value. Following the peripheral nerve block, transcutaneous stimulation will be repeated and, if still possible to elicit quadriceps contractions in response to electrical stimulation, the resulting new threshold amperage will be measured. The new threshold amperage will be expressed as a percentage of the baseline value and serve as a quantitative functional indication of the extent of quadriceps paresis resulting from the peripheral nerve block. The primary outcome will be quadriceps paralysis - yes/no.
Time Frame
15 minutes after the placement of the peripheral nerve block (femoral or adductor canal)
Secondary Outcome Measure Information:
Title
Threshold amperage as a percentage of the baseline value
Description
Following the peripheral nerve block, transcutaneous stimulation will be repeated and, if still possible to elicit quadriceps contractions in response to electrical stimulation, the resulting new threshold amperage will be measured. The new threshold amperage will be expressed as a percentage of the baseline value and serve as a quantitative functional indication of the extent of quadriceps paresis resulting from the peripheral nerve block.
Time Frame
15 minutes after the placement of the peripheral nerve block
Title
Analgesic adequacy
Description
Analgesic adequacy as determined by pain scores (0-10) at spinal resolution (on average 2 hours post-op), 24 hours post-op and 48 hours post-op and daily epidural patient controlled analgesia consumption
Time Frame
Resolution of the spinal anesthetic (2 hours post-op), 24 and 48 hours post-op
Title
Ability to complete a straight leg lift
Description
Ability to complete and hold (for 3 seconds) a straight leg lift (from supine position) against gravity as evidence of meaningful quadriceps function - performed in holding area (baseline), at spinal resolution (on average 2 hours post-op), 24 hours post-op and 48 hours post-op
Time Frame
Holding area (baseline), at spinal resolution (2 hours post-op), 24 hours post-op and 48 hours post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing primary unilateral total knee arthroplasty Planned use of combined spinal epidural (CSE) anesthesia Ability to follow study protocol Exclusion Criteria: Contraindication to a spinal or epidural anesthetic Chronic opioid use (defined as daily or almost daily use of opioids for >3 months) Allergy to local anesthetics Pre-existing neuropathy or weakness of the operative limb Any neuromuscular disorder Diabetes type I and II Contraindication to a femoral nerve block or adductor canal nerve block Allergy or intolerance to any of the study medications BMI > 35 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Urmey, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9024035
Citation
Vloka JD, Hadzic A, Lesser JB, Kitain E, Geatz H, April EW, Thys DM. A common epineural sheath for the nerves in the popliteal fossa and its possible implications for sciatic nerve block. Anesth Analg. 1997 Feb;84(2):387-90. doi: 10.1097/00000539-199702000-00028.
Results Reference
result
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
result
Links:
URL
http://www.hss.edu
Description
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Total Knee Arthroplasty Utilizing Adductor Canal Block: Effect on Quadriceps Sparing

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