High Versus Low Adductor Canal Block

October 29, 2020 updated by: Carilion Clinic

Ultrasound Guided Adductor Canal Block vs Intra-Operative Trans-Articular Saphenous Nerve Block: A Prospective Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study Design: Prospective RCT

Study Question- Does a surgeon administered intra-operative adductor canal block ("Low-ACB") provide non-inferior post-operative pain relief relative to anesthesia administered, ultrasound guided adductor canal block ("High-ACB").

Hypothesis- Surgeon administered Low-ACB provides non-inferior pain relief relative to anesthesia administered High-ACB.

Study Groups-

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

Randomization- Cluster Randomization There will be two surgeons collecting data for this study; Surgeon A (principal investigator) & Surgeon B. 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.

Participant Timeline:

The investigators will interact with patients and collect specific data at a limited number of office visits as outlined below. All office appointments will take place at the Carilion Clinic Institute for Orthopaedics and Neurosciences.

  1. Pre-Op Appointment- Thorough informed consent will be obtained at this visit. Patient will be sent home with consent form to review further and discuss with family.
  2. Day of Surgery- Prior to surgery, operative team will go over consent one final time and obtain signature if patient consents.
  3. Post-Op Admission- Standard post-op protocol will be followed. Data will be collected from this admission from the Epic EMR as above.
  4. Discharge Home- Patient will keep pill journal for opioid narcotics taken each day as well as a recording their daily pain score prior to bed.
  5. 2 Week F/U Appointment- PROMIS, KOOS Jr. and VAS scores as well as physical exam data recorded. This requires no additional time as this is part of routine post TKA follow up.
  6. Home 2-6 Weeks- Patient will keep pill journal for opioid narcotics taken each day as well as a recording their daily pain score prior to bed.
  7. 6 Week F/U Appointment- PROMIS, KOOS Jr. and VAS scores as well as physical exam data recorded. This requires no additional time as this is part of routine post TKA follow up.

At this point, the patient has completed their participation in the study and will continue follow up as scheduled without further data collection.

Technical Details:

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 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.[3] 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.

Anesthesia Administered Group 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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Institute for Orthopaedics & Neurosciences

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Consumption
Time Frame: Up to 48 hours after surgery
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
Up to 48 hours after surgery
Narcotic Consumption
Time Frame: through study completion, an average of 6 weeks
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
through study completion, an average of 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: through study completion, an average of 6 weeks
Length of hospital stay after surgery measured in hours
through study completion, an average of 6 weeks
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.
Recorded hourly while in hospital, daily after discharge up until 6wks
Inpatient therapy
Time Frame: Up to 48 hours after surgery
Number of steps taken at each therapy session while in the hospital
Up to 48 hours after surgery
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.
through study completion, an average of 6 weeks
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.
through study completion, an average of 6 weeks
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.
through study completion, an average of 6 weeks

Collaborators and Investigators

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

Sponsor

Carilion Clinic

Investigators

  • Principal Investigator: John W Mann, MD, Carilion Clinic

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

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 (ACTUAL)

March 11, 2020

Primary Completion (ANTICIPATED)

December 30, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (ACTUAL)

November 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-19-643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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