High Versus Low Adductor Canal Block

NCT04155983 | Unknown Phase 4 FDA Drug

• 1 other identifier: IRB-19-643
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

gonarthrosis; osteoarthritis; knee; total knee arthroplasty; adductor canal block; saphenous nerve block; multimodal pain control

Outcome Measures

Primary Outcomes (2)

• Narcotic Consumption

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

  Up to 48 hours after surgery

• Narcotic Consumption

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

  through study completion, an average of 6 weeks

Secondary Outcomes (6)

• Length of stay

  through study completion, an average of 6 weeks

• Visual Analog Scale Pain Scores

  Recorded hourly while in hospital, daily after discharge up until 6wks

• Inpatient therapy

  Up to 48 hours after surgery

• Patient Reported Outcome Measure Information System 10 Score

  through study completion, an average of 6 weeks

• Knee injury and Osteoarthritis Outcome Score Junior

  through study completion, an average of 6 weeks

Study Arms (2)

High ACB

ACTIVE COMPARATOR

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

Low ACB

ACTIVE COMPARATOR

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

Interventions

Ropivacaine DRUG

The drug will be administered in the same dosage in both arms. The location of the injection will vary by arm.

Also known as: naropin

High ACB; Low ACB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Institute for Orthopaedics & Neurosciences

Roanoke, Virginia, 24014, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 21039357 BACKGROUND

• 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.

  PMID: 22221014 BACKGROUND

• 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.

  PMID: 22335278 BACKGROUND

• 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.

  PMID: 26996675 BACKGROUND

• 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.

  PMID: 29529612 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• John W Mann, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara F Smith

CONTACT

(540) 525-4917; sfsmith@carilionclinic.org

John V Horberg, MD

CONTACT

(540) 655-8946; johnvhorbergmd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 7, 2019
• Study Start: March 11, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)