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Single Dose Adductor Canal Block vs SPANK Block for TKA

Primary Purpose

Osteo Arthritis Knee, Pain, Postoperative, Pain, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SPANK Block (Sensory Posterior Articular Nerves of the Knee)
Adductor Canal Block
Ropivacaine Hcl 0.5% Inj Vil 30Ml
Pajunk sonoplex stim needle
Sponsored by
San Antonio Uniformed Services Health Education Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Total Knee Arthroplasty, SPANK Block, Adductor Canal Block, Regional Anesthesia

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients between the ages of 40 and 80 years old undergoing total knee arthroplasty amenable to peripheral nerve block for perioperative analgesia.
  • BMI <45
  • ASA class III or less

Exclusion Criteria:

  • Inability to sign consent form
  • Allergy to medications used in the study
  • Repeat surgery
  • History of seizure disorder
  • Simultaneous bilateral TKA
  • History of substance abuse
  • BMI >45
  • Opioid consumption of greater or equal to 30mg morphine equivalents per day
  • Age <40 or >80 years old
  • ASA IV or greater
  • Inability to use a PCA
  • Inability to access the intrathecal space
  • Infection at the site of injection (either for spinal or PNB)
  • INR greater than or equal to 1.4

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Adductor Canal Block Alone

    SPANK Block Plus Adductor Canal Block

    Arm Description

    Control arm to receive Adductor Canal Block without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance

    Experimental arm to receive Adductor Canal Block plus SPANK Block (Sensory Posterior Articular Nerves of the Knee) without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance into the adductor canal plus 20cc ropivacaine 0.5% injected into the posterior tissues of the knee

    Outcomes

    Primary Outcome Measures

    Postoperative Opioid Consumption
    Amount of opioids used within the first 24 hours post-operatively, starting from when the patient leaves the operating room, measured in PO morphine equivalents

    Secondary Outcome Measures

    Postoperative Pain Scores
    Verbal pain score measured via numerical rating scale from 1-10 at 4 hrs, 8 hrs, 12hrs, 16hrs, and 24 hours.
    Time to first opioid use
    The amount of time measured from when the patient leaves the operating room to the time when they receive their first dose of any opioid medication.

    Full Information

    First Posted
    March 13, 2018
    Last Updated
    April 12, 2019
    Sponsor
    San Antonio Uniformed Services Health Education Consortium
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03502889
    Brief Title
    Single Dose Adductor Canal Block vs SPANK Block for TKA
    Official Title
    Single Dose Adductor Canal Block With SPANK (Sensory Posterior Articular Nerves of the Knee) Block Compared to Single Dose Adductor Canal Block and Pain Control After Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2019 (Anticipated)
    Primary Completion Date
    April 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    San Antonio Uniformed Services Health Education Consortium

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a prospective, randomized control trial to compare SPANK block combined with adductor canal block to adductor canal block alone in treatment of post-operative pain after total knee arthroplasty. The primary outcome is pain control, which will be measured throughout the post-operative course using morphine equivalents of opioid analgesics used during the first 24 hours after surgery. Secondary outcomes include pain scores recorded at 4, 8, 12, 16, 20, and 24 hours post-operatively, cumulative pain score, incidence of post-operative nausea and vomiting, and extent of motor blockade. The study will aid in answering the question of whether SPANK block is an effective adjunct in preventing pain and decreasing opioid requirement after TKA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteo Arthritis Knee, Pain, Postoperative, Pain, Acute
    Keywords
    Total Knee Arthroplasty, SPANK Block, Adductor Canal Block, Regional Anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adductor Canal Block Alone
    Arm Type
    Active Comparator
    Arm Description
    Control arm to receive Adductor Canal Block without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance
    Arm Title
    SPANK Block Plus Adductor Canal Block
    Arm Type
    Experimental
    Arm Description
    Experimental arm to receive Adductor Canal Block plus SPANK Block (Sensory Posterior Articular Nerves of the Knee) without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance into the adductor canal plus 20cc ropivacaine 0.5% injected into the posterior tissues of the knee
    Intervention Type
    Procedure
    Intervention Name(s)
    SPANK Block (Sensory Posterior Articular Nerves of the Knee)
    Intervention Description
    Injection of local anesthetic into the tissues on the posterior aspect of the knee to provide sensory blockade of the articular nerves of the knee.
    Intervention Type
    Procedure
    Intervention Name(s)
    Adductor Canal Block
    Intervention Description
    Injection of local anesthetic into the inner thigh under ultrasound guidance to provide sensory blockade to the anterior aspect of the knee
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine Hcl 0.5% Inj Vil 30Ml
    Intervention Description
    Amide local anesthetic, this concentration is commonly used to achieve surgical level anesthesia. The drug itself is not being studied and the same concentration will be used in all participants.
    Intervention Type
    Device
    Intervention Name(s)
    Pajunk sonoplex stim needle
    Intervention Description
    Echogenic needle used for ultrasound guided nerve blockade.
    Primary Outcome Measure Information:
    Title
    Postoperative Opioid Consumption
    Description
    Amount of opioids used within the first 24 hours post-operatively, starting from when the patient leaves the operating room, measured in PO morphine equivalents
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Postoperative Pain Scores
    Description
    Verbal pain score measured via numerical rating scale from 1-10 at 4 hrs, 8 hrs, 12hrs, 16hrs, and 24 hours.
    Time Frame
    4, 8, 12, 16, and 24 hours postoperatively
    Title
    Time to first opioid use
    Description
    The amount of time measured from when the patient leaves the operating room to the time when they receive their first dose of any opioid medication.
    Time Frame
    24 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients between the ages of 40 and 80 years old undergoing total knee arthroplasty amenable to peripheral nerve block for perioperative analgesia. BMI <45 ASA class III or less Exclusion Criteria: Inability to sign consent form Allergy to medications used in the study Repeat surgery History of seizure disorder Simultaneous bilateral TKA History of substance abuse BMI >45 Opioid consumption of greater or equal to 30mg morphine equivalents per day Age <40 or >80 years old ASA IV or greater Inability to use a PCA Inability to access the intrathecal space Infection at the site of injection (either for spinal or PNB) INR greater than or equal to 1.4
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angela M Curell, MD
    Phone
    (210) 220-7450
    Email
    angela.m.curell2.mil@mail.mil
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gregory Stevens, MD
    Phone
    (210) 916-2014
    Email
    gregory.j.stevens.mil@mail.mil
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angela M Curell, MD
    Organizational Affiliation
    San Antonio Uniformed Services Health Education Consortium
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    If shared, will plan to provide. All IPD that underlie results in publication Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Starting 6 months after publication
    Citations:
    PubMed Identifier
    28288050
    Citation
    Terkawi AS, Mavridis D, Sessler DI, Nunemaker MS, Doais KS, Terkawi RS, Terkawi YS, Petropoulou M, Nemergut EC. Pain Management Modalities after Total Knee Arthroplasty: A Network Meta-analysis of 170 Randomized Controlled Trials. Anesthesiology. 2017 May;126(5):923-937. doi: 10.1097/ALN.0000000000001607.
    Results Reference
    background
    PubMed Identifier
    27322397
    Citation
    Gao F, Ma J, Sun W, Guo W, Li Z, Wang W. Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Total Knee Arthroplasty: A Systematic Review and Meta-analysis. Clin J Pain. 2017 Apr;33(4):356-368. doi: 10.1097/AJP.0000000000000402.
    Results Reference
    background
    PubMed Identifier
    28079176
    Citation
    Wang D, Yang Y, Li Q, Tang SL, Zeng WN, Xu J, Xie TH, Pei FX, Yang L, Li LL, Zhou ZK. Adductor canal block versus femoral nerve block for total knee arthroplasty: a meta-analysis of randomized controlled trials. Sci Rep. 2017 Jan 12;7:40721. doi: 10.1038/srep40721. Erratum In: Sci Rep. 2021 Jul 21;11(1):15230.
    Results Reference
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    PubMed Identifier
    28273133
    Citation
    Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017.
    Results Reference
    background
    PubMed Identifier
    26611901
    Citation
    Li D, Ma GG. Analgesic efficacy and quadriceps strength of adductor canal block versus femoral nerve block following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2614-9. doi: 10.1007/s00167-015-3874-3. Epub 2015 Nov 26.
    Results Reference
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    PubMed Identifier
    25111605
    Citation
    Bauer MC, Pogatzki-Zahn EM, Zahn PK. Regional analgesia techniques for total knee replacement. Curr Opin Anaesthesiol. 2014 Oct;27(5):501-6. doi: 10.1097/ACO.0000000000000115.
    Results Reference
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    PubMed Identifier
    24581899
    Citation
    Pelt CE, Anderson AW, Anderson MB, Van Dine C, Peters CL. Postoperative falls after total knee arthroplasty in patients with a femoral nerve catheter: can we reduce the incidence? J Arthroplasty. 2014 Jun;29(6):1154-7. doi: 10.1016/j.arth.2014.01.006. Epub 2014 Jan 16.
    Results Reference
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    PubMed Identifier
    24641894
    Citation
    Baratta JL, Gandhi K, Viscusi ER. Perioperative pain management for total knee arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):22-36. doi: 10.3113/jsoa.2014.0022.
    Results Reference
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    PubMed Identifier
    24401769
    Citation
    Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
    Results Reference
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    PubMed Identifier
    23265274
    Citation
    Wasserstein D, Farlinger C, Brull R, Mahomed N, Gandhi R. Advanced age, obesity and continuous femoral nerve blockade are independent risk factors for inpatient falls after primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1121-4. doi: 10.1016/j.arth.2012.08.018. Epub 2012 Dec 21.
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    PubMed Identifier
    19553071
    Citation
    Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.
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