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

January 29, 2016 updated by: Hospital for Special Surgery, New York

Postoperative Pain Management Following Total Knee Arthroplasty Utilizing Adductor Canal Block: Effects on Pain Management and Quadriceps Sparing

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

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
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High volume Adductor canal block
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
Procedure: High Volume Adductor Canal Block
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
Experimental: Low volume Adductor Canal Block
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
Procedure: Low Volume Adductor Canal Block
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
Experimental: Femoral nerve block
Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine
Procedure: Femoral Nerve Block
Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve
Time Frame: 15 minutes after the placement of the peripheral nerve block (femoral or adductor canal)
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.
15 minutes after the placement of the peripheral nerve block (femoral or adductor canal)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Threshold amperage as a percentage of the baseline value
Time Frame: 15 minutes after the placement of the peripheral nerve block
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.
15 minutes after the placement of the peripheral nerve block
Analgesic adequacy
Time Frame: Resolution of the spinal anesthetic (2 hours post-op), 24 and 48 hours post-op
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
Resolution of the spinal anesthetic (2 hours post-op), 24 and 48 hours post-op
Ability to complete a straight leg lift
Time Frame: Holding area (baseline), at spinal resolution (2 hours post-op), 24 hours post-op and 48 hours post-op
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
Holding area (baseline), at spinal resolution (2 hours post-op), 24 hours post-op and 48 hours post-op

Collaborators and Investigators

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

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: William Urmey, MD, Hospital for Special Surgery, New York

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

Helpful Links

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

February 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #2014-005

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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