search
Back to results

High Versus Low Adductor Canal Block

Primary Purpose

Osteo Arthritis Knee

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring gonarthrosis, osteoarthritis, knee, total knee arthroplasty, adductor canal block, saphenous nerve block, multimodal pain control

Eligibility Criteria

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

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

Sites / Locations

  • Carilion Institute for Orthopaedics & NeurosciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High ACB

Low ACB

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Narcotic Consumption
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
Narcotic Consumption
Post-operative narcotic utilization measured in Morphine Equivalents per hour.

Secondary Outcome Measures

Length of stay
Length of hospital stay after surgery measured in hours
Visual Analog Scale Pain Scores
10 point validated patient reported pain scores with 0 being no pain and 10 being the worst pain the patient can imagine.
Inpatient therapy
Number of steps taken at each therapy session while in the hospital
Patient Reported Outcome Measure Information System 10 Score
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.
Knee injury and Osteoarthritis Outcome Score Junior
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.
Range of Motion
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.

Full Information

First Posted
November 4, 2019
Last Updated
October 29, 2020
Sponsor
Carilion Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT04155983
Brief Title
High Versus Low Adductor Canal Block
Official Title
Ultrasound Guided Adductor Canal Block vs Intra-Operative Trans-Articular Saphenous Nerve Block: A Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carilion Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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- US Guided, Anesthesia Administered Adductor Canal Block ("High ACB") 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. 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. Day of Surgery- Prior to surgery, operative team will go over consent one final time and obtain signature if patient consents. Post-Op Admission- Standard post-op protocol will be followed. Data will be collected from this admission from the Epic EMR as above. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
gonarthrosis, osteoarthritis, knee, total knee arthroplasty, adductor canal block, saphenous nerve block, multimodal pain control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High ACB
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low ACB
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
naropin
Intervention Description
The drug will be administered in the same dosage in both arms. The location of the injection will vary by arm.
Primary Outcome Measure Information:
Title
Narcotic Consumption
Description
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
Time Frame
Up to 48 hours after surgery
Title
Narcotic Consumption
Description
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
Time Frame
through study completion, an average of 6 weeks
Secondary Outcome Measure Information:
Title
Length of stay
Description
Length of hospital stay after surgery measured in hours
Time Frame
through study completion, an average of 6 weeks
Title
Visual Analog Scale Pain Scores
Description
10 point validated patient reported pain scores with 0 being no pain and 10 being the worst pain the patient can imagine.
Time Frame
Recorded hourly while in hospital, daily after discharge up until 6wks
Title
Inpatient therapy
Description
Number of steps taken at each therapy session while in the hospital
Time Frame
Up to 48 hours after surgery
Title
Patient Reported Outcome Measure Information System 10 Score
Description
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.
Time Frame
through study completion, an average of 6 weeks
Title
Knee injury and Osteoarthritis Outcome Score Junior
Description
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.
Time Frame
through study completion, an average of 6 weeks
Title
Range of Motion
Description
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.
Time Frame
through study completion, an average of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara F Smith
Phone
(540) 525-4917
Email
sfsmith@carilionclinic.org
First Name & Middle Initial & Last Name or Official Title & Degree
John V Horberg, MD
Phone
(540) 655-8946
Email
johnvhorbergmd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Mann, MD
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Institute for Orthopaedics & Neurosciences
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Smith, MSN
Phone
540-512-1056
Email
sfsmith@carilionclinic.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21039357
Citation
Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.
Results Reference
background
PubMed Identifier
22221014
Citation
Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
Results Reference
background
PubMed Identifier
22335278
Citation
Kapoor R, Adhikary SD, Siefring C, McQuillan PM. The saphenous nerve and its relationship to the nerve to the vastus medialis in and around the adductor canal: an anatomical study. Acta Anaesthesiol Scand. 2012 Mar;56(3):365-7. doi: 10.1111/j.1399-6576.2011.02645.x.
Results Reference
background
PubMed Identifier
26996675
Citation
Pepper AM, North TW, Sunderland AM, Davis JJ. Intraoperative Adductor Canal Block for Augmentation of Periarticular Injection in Total Knee Arthroplasty: A Cadaveric Study. J Arthroplasty. 2016 Sep;31(9):2072-6. doi: 10.1016/j.arth.2016.02.030. Epub 2016 Feb 26.
Results Reference
background
PubMed Identifier
29529612
Citation
Kavolus JJ, Sia D, Potter HG, Attarian DE, Lachiewicz PF. Saphenous Nerve Block From Within the Knee Is Feasible for TKA: MRI and Cadaveric Study. Clin Orthop Relat Res. 2018 Jan;476(1):30-36. doi: 10.1007/s11999.0000000000000006.
Results Reference
background

Learn more about this trial

High Versus Low Adductor Canal Block

We'll reach out to this number within 24 hrs