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IPACK Nerve Block for Total Knee Arthroplasty

Primary Purpose

Arthropathy of Knee, Anesthesia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
Ochsner Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee

Eligibility Criteria

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

Inclusion Criteria:

  • Unilateral, primary tricompartment total knee arthroplasty
  • Age 18 years or older
  • ASA I-III
  • Eligible for spinal or combined spinal epidural anesthetic
  • Able to speak, read, and understand English
  • Willing to participate in the trial

Exclusion Criteria:

  • Contraindication to regional anesthesia or peripheral nerve blocks
  • Allergy to local anesthetics
  • Allergy to NSAIDs
  • Chronic renal insufficiency with Cr > 1.4 or GFR < 60
  • Have chronic pain that is not related to their knee joint
  • Have been using opioids on a chronic basis (daily or almost daily opioid use for 3 months or longer)
  • Have a pre-existing peripheral neuropathy involving the operative site
  • Body mass index greater than or equal to 40

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    continuous ACB with IPACK block

    continuous ACB with sham subcutaneous saline injection

    Arm Description

    ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and IPACK block with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine

    ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh

    Outcomes

    Primary Outcome Measures

    Cumulative opioid consumption (morphine equivalents) in the first 24 hours

    Secondary Outcome Measures

    Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey
    Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
    Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
    Walk distance on POD#1 am, POD#1 pm, POD#2
    Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room
    Time to oral-only opioids
    Pain location
    Hospital length of stay
    Incidence of foot drop
    Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm
    Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score

    Full Information

    First Posted
    April 10, 2019
    Last Updated
    April 15, 2019
    Sponsor
    Ochsner Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03921034
    Brief Title
    IPACK Nerve Block for Total Knee Arthroplasty
    Official Title
    Pain After Total Knee Arthroplasty: a Comparison of Combined Continuous Adductor Canal Block With Infiltration of Local Anesthetic Between the Popliteal Artery and Capsule of the Knee Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 17, 2016 (Actual)
    Primary Completion Date
    January 23, 2018 (Actual)
    Study Completion Date
    January 23, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ochsner Health System

    4. Oversight

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

    5. Study Description

    Brief Summary
    Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA. Enrolled patients will be randomized to either continuous ACB with IPACK or to continuous ACB with sham subcutaneous saline injection. Outcomes assessors and patients will be blinded to the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthropathy of Knee, Anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Masking Description
    Only the regional anesthesiologist performing the block will know the randomization status. The study participants, outcome assessors/researchers, other anesthesia personnel, surgeons, physician assistants, and nurses will be blinded to the treatment arm.
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    continuous ACB with IPACK block
    Arm Type
    Active Comparator
    Arm Description
    ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and IPACK block with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine
    Arm Title
    continuous ACB with sham subcutaneous saline injection
    Arm Type
    Sham Comparator
    Arm Description
    ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    Naropin
    Intervention Description
    All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Intervention Description
    All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.
    Primary Outcome Measure Information:
    Title
    Cumulative opioid consumption (morphine equivalents) in the first 24 hours
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey
    Time Frame
    through study completion approximately 2 days
    Title
    Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
    Time Frame
    through study completion approximately 2 days
    Title
    Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
    Time Frame
    through study completion approximately 2 days
    Title
    Walk distance on POD#1 am, POD#1 pm, POD#2
    Time Frame
    through study completion approximately 2 days
    Title
    Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room
    Time Frame
    through study completion approximately 2 days
    Title
    Time to oral-only opioids
    Time Frame
    through study completion approximately 2 days
    Title
    Pain location
    Time Frame
    through study completion approximately 2 days
    Title
    Hospital length of stay
    Time Frame
    through study completion approximately 2 days
    Title
    Incidence of foot drop
    Time Frame
    through study completion approximately 2 days
    Title
    Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm
    Time Frame
    through study completion approximately 2 days
    Title
    Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score
    Time Frame
    through study completion approximately 2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unilateral, primary tricompartment total knee arthroplasty Age 18 years or older ASA I-III Eligible for spinal or combined spinal epidural anesthetic Able to speak, read, and understand English Willing to participate in the trial Exclusion Criteria: Contraindication to regional anesthesia or peripheral nerve blocks Allergy to local anesthetics Allergy to NSAIDs Chronic renal insufficiency with Cr > 1.4 or GFR < 60 Have chronic pain that is not related to their knee joint Have been using opioids on a chronic basis (daily or almost daily opioid use for 3 months or longer) Have a pre-existing peripheral neuropathy involving the operative site Body mass index greater than or equal to 40
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matthew Patterson, MD
    Organizational Affiliation
    Ochsner
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No plan

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    IPACK Nerve Block for Total Knee Arthroplasty

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