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High Versus Low Adductor Canal Block

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ClinicalTrials.gov Identifier: NCT04155983
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Carilion Clinic

Brief Summary:
The investigators will be comparing the efficacy of two different techniques for performing an adductor canal block to the saphenous nerve as a part of the multimodal pain control regimen for total knee arthroplasty. The investigators will be comparing a "low adductor canal block" in which the surgeon administers local anesthetic to the distal aspect of the nerve from the operative site to a "high adductor canal block" in which the anesthesiologist administers the local anesthetic more proximally along the thigh using ultrasound guidance. The investigators will power the study for non-inferiority to compare the newer "low" block to the more commonly performed and more widely studied "high" block.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Drug: Ropivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Study Design: Prospective RCT

Study Groups:

US Guided, Anesthesia Administered Adductor Canal Block ("High ACB") Intra-Operative, Surgeon Administered Adductor Canal Block ("Low ACB")

Model- Cluster Randomization There will be two surgeons collecting data for this study; Dr. Mann (principal investigator) & Dr. Moskal. Each surgeon will begin collecting data on opposite arms of the study. Surgeon A will perform 35 consecutive High-ACB knees while Surgeon B performs 35 Low-ACB knees. After performing 35 knees under either the High-ACB or Low-ACB protocol, Surgeon A and Surgeon B will switch arms and perform an additional 35 consecutive knees in the opposite arm. At trial's end, each surgeon will have performed 35 TKAs using the High-ACB and Low-ACB protocol yielding a total of 70 patients in each arm.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Adductor Canal Block vs Intra-Operative Trans-Articular Saphenous Nerve Block: A Prospective Trial
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High ACB
In the pre-operative cohort, the adductor canal block is administered by anesthesia staff immediately prior to patient transport to the operating room. The thigh is prepped with cholorhexidine at the midpoint between the anterior superior iliac spine and the patella and sterile drapes are applied. An ultrasound probe is then used to localize the adductor canal and confirm that the femoral artery, femoral vein and saphenous nerve can be visualized deep to the sartorious. The probe is moved proximally or distally until the neurovascular bundle is centered under the sartorius. A 20cc syringe with a blunt tip 1.5in 18ga needle is then used to inject 15cc of 0.5% ropivocaine. Following this, the wound is prepped and draped in usual sterile fashion for the arthroplasty procedure.
Drug: Ropivacaine
The drug will be administered in the same dosage in both arms. The location of the injection will vary by arm.
Other Name: naropin

Active Comparator: Low ACB
Surgeon Administered Group In the intra-operative cohort, the block will be administered after the final components are in place and cement debris is removed. The knee joint is irrigated with dilute hibiclens or betadine followed by pulsatile lavage per institutional protocol. A blunt tip 1.5in 18ga needle was then used to administer 15cc of 0.5% ropivocaine.. The location of the saphenous nerve as it exits the adductor canal will be estimated to be 1.5x the TEA proximal to the medial epicondyle in men and 1.3x the TEA proximal in women as described by Kavolus et al. The 60cc of the anesthetic will then injected through the vastus medialis musculature in a field extending from 1cm proximal to one cm distal to the assumed location of the nerve with the needle directed in from 20° to 45° medial. The wound is then irrigated pulsatile lavage one final time and closed in layered fashion.
Drug: Ropivacaine
The drug will be administered in the same dosage in both arms. The location of the injection will vary by arm.
Other Name: naropin




Primary Outcome Measures :
  1. Narcotic Consumption [ Time Frame: Up to 48 hours after surgery ]
    Post-operative narcotic utilization measured in Morphine Equivalents per hour.

  2. Narcotic Consumption [ Time Frame: through study completion, an average of 6 weeks ]
    Post-operative narcotic utilization measured in Morphine Equivalents per hour.


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: through study completion, an average of 6 weeks ]
    Length of hospital stay after surgery measured in hours

  2. Visual Analog Scale Pain Scores [ Time Frame: Recorded hourly while in hospital, daily after discharge up until 6wks ]
    10 point validated patient reported pain scores with 0 being no pain and 10 being the worst pain the patient can imagine.

  3. Inpatient therapy [ Time Frame: Up to 48 hours after surgery ]
    Number of steps taken at each therapy session while in the hospital

  4. Patient Reported Outcome Measure Information System 10 Score [ Time Frame: through study completion, an average of 6 weeks ]
    validated outcome measure using 10 questions and scored on a 50 point scale with 0 being the worst and 50 being the best overall score.

  5. Knee injury and Osteoarthritis Outcome Score Junior [ Time Frame: through study completion, an average of 6 weeks ]
    validated outcome measure using 7 questions and scored on a 100 point scale such that 100 is the best score and 0 is the worst.

  6. Range of Motion [ Time Frame: through study completion, an average of 6 weeks ]
    the flexion and extension range of motion in degrees of the patient recorded using a goniometer by the physical therapist while in the hospital and surgeon while in the clinic for follow up visits. Normal range of motion is 0-120 degrees.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing unilateral primary TKA for primary osteoarthritis
  • Age over 18

Exclusion Criteria:

  • Pre-operative narcotic use
  • Bilateral procedure
  • Non-Primary arthroplasty
  • Workman's comp
  • Inability to have spinal anesthesia (blood thinners)
  • Unsuccessful spinal anesthesia
  • Inflammatory or Post Traumatic arthritis
  • ASA score of 4
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155983


Contacts
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Contact: Sara F Smith (540) 525-4917 sfsmith@carilionclinic.org
Contact: John V Horberg, MD (540) 655-8946 johnvhorbergmd@gmail.com

Sponsors and Collaborators
Carilion Clinic
Investigators
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Principal Investigator: John W Mann, MD Carilion Clinic
Publications:
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Responsible Party: Carilion Clinic
ClinicalTrials.gov Identifier: NCT04155983    
Other Study ID Numbers: IRB-19-643
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Carilion Clinic:
gonarthrosis
osteoarthritis
knee
total knee arthroplasty
adductor canal block
saphenous nerve block
multimodal pain control
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents