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Pain Levels and Opioid Usage in Three Nerve Block Cohorts in Primary TKA

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ClinicalTrials.gov Identifier: NCT04292392
Recruitment Status : Withdrawn (Final protocol and ICF has not been approved by local IRB. No subjects have been enrolled. Study will not be pursued due to current COVID-19 pandemic.)
First Posted : March 3, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Arthur Malkani, University of Louisville

Brief Summary:
The primary objective of this study is to compare effect of combined block of ACB (adductor canal block) with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block and/or Intra-articular block in immediate postoperative and early postop rehabilitation and pain management in patients undergoing primary TKA. The secondary objective is to review both in-hospital and post-discharge pain levels and narcotic usage of primary TKAs, with a minimum 6-week postoperative follow-up.

Condition or disease Intervention/treatment Phase
Knee Arthropathy Other: preop ACB, followed by Intra-articular block during TKA surgery Other: preop ACB+IPACK block Other: preop ACB+IPACK block, followed by Intra-articular block during TKA surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Comparison of Pain Levels and Opioid Usage in ACB + Periarticular Block vs. ACB + IPACK Block vs. ACB + IPACK + Periarticular Block in Patients Undergoing Primary TKA
Actual Study Start Date : April 6, 2020
Actual Primary Completion Date : August 15, 2020
Actual Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: A - ACB + Periarticular Block
Group A: patient will receive a preop ACB, followed by Intra-articular block during TKA surgery
Other: preop ACB, followed by Intra-articular block during TKA surgery

Preoperative ACB (adductor canal block), followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts:

  • Ropivacaine 5mg/ml (49.25ml)
  • Epinephrine 1mg/ml (0.5ml)
  • Ketorolac 30mg/ml (1ml)
  • Clonidine 0.1mg/ml (0.8ml)
  • Saline 48.45ml

Experimental: B - ACB + IPACK Block
Group B: patient will receive a preop ACB+IPACK block before TKA surgery only
Other: preop ACB+IPACK block
Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block

Experimental: C - ACB + IPACK + Periarticular Block
Group C: patient will receive a preop ACB+IPACK block, followed by Intra-articular block during TKA surgery
Other: preop ACB+IPACK block, followed by Intra-articular block during TKA surgery

Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block, followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts:

  • Ropivacaine 5mg/ml (49.25ml)
  • Epinephrine 1mg/ml (0.5ml)
  • Ketorolac 30mg/ml (1ml)
  • Clonidine 0.1mg/ml (0.8ml)
  • Saline 48.45ml




Primary Outcome Measures :
  1. total length of hospital stay [ Time Frame: outcome measure will be taken at 2 weeks postoperatively ]
    total length of hospital stay as defined by number of days from date of surgery to date of discharge

  2. Knee Society Score [ Time Frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively.] ]
    Knee Society Score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. A higher value represents a better outcome

  3. WOMAC score [ Time Frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively ]
    WOMAC score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome.

  4. Visual Analog Scale [ Time Frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively ]
    The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.

  5. Amount of narcotic medication utilized [ Time Frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively ]
    Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).

  6. Ability to rise from a chair independently [ Time Frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively ]
    Ability to rise from a chair independently (Yes/No)

  7. Active range-of-motion (ROM) [ Time Frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively ]
    Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)

  8. Distance that patient is able to walk [ Time Frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively ]
    Distance that patient is able to walk, as measured in feet

  9. Use of an ambulatory assistive device [ Time Frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, 6 weeks (± 2 weeks) postoperatively ]
    Use of an ambulatory assistive device (Yes/No)

  10. Incidence of postop complications [ Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively ]
    Incidence of any postoperative complication that involves hospital readmission and/or a re-operation of the surgical knee.



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Ages Eligible for Study:   22 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is indicated for a primary, unilateral TKA secondary to osteoarthritis.
  2. Patient age is 22-89 at time of TKA surgery.
  3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document.
  4. Patient is able to read and speak English.

Exclusion Criteria:

  1. Patient is under the age of 22 or over the age of 89.
  2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis).
  3. Patient is scheduled to undergo a bilateral TKA surgery.
  4. Patient is unable to read and speak English.

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): NCT04292392


Locations
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United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Arthur L Malkani, MD University of Louisville
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Responsible Party: Arthur Malkani, Professor, Adult Reconstruction, Dept. of Orthopaedic Surgery, University of Louisville
ClinicalTrials.gov Identifier: NCT04292392    
Other Study ID Numbers: 20.0132
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases