IPACK Nerve Block for Total Knee Arthroplasty

Ketamine

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.

Intervention / Treatment

  • Ropivacaine (DRUG)
    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.
  • Saline (DRUG)
    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.

Condition or Disease

  • Arthropathy of Knee
  • Anesthesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 72 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    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.

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Nov 17, 2016 ACTUAL
    Primary Completion: Jan 23, 2018 ACTUAL
    Completion Date: Jan 23, 2018 ACTUAL
    Study First Posted: Apr 19, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 15, 2019

    Sponsors / Collaborators

    Lead Sponsor: Ochsner Health System
    Responsible Party: N/A

    Participant Groups

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Cumulative opioid consumption (morphine equivalents) in the first 24 hours 24 hours
    Secondary Outcomes
    • Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey through study completion approximately 2 days
    • Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm through study completion approximately 2 days
    • Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm through study completion approximately 2 days
    • Walk distance on POD#1 am, POD#1 pm, POD#2 through study completion approximately 2 days
    • Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room through study completion approximately 2 days
    • Time to oral-only opioids through study completion approximately 2 days
    • Pain location through study completion approximately 2 days
    • Hospital length of stay through study completion approximately 2 days
    • Incidence of foot drop through study completion approximately 2 days
    • Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm through study completion approximately 2 days
    • Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score through study completion approximately 2 days

    More Details

    NCT Number: NCT03921034
    Other IDs: 2016.307.C
    Study URL: https://clinicaltrials.gov/study/NCT03921034
    Last updated: Sep 29, 2023