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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

IPACK Nerve Block for Total Knee Arthroplasty

Clinicaltrials.gov identifier NCT03921034

Recruitment Status Completed

First Posted April 19, 2019

Last update posted April 19, 2019

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.

  • Condition or Disease:Anesthesia
    Arthropathy of Knee
  • Intervention/Treatment: Drug: Ropivacaine
    Drug: Saline
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 72 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Care Provider)
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: November 2016
  • Actual Primary Completion Date: January 2018
  • Actual Study Completion Date: January 2018
Arms and interventions
Arm Intervention/treatment
Active Comparator: continuous ACB with IPACK block
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
Drug: Ropivacaine
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.
Sham Comparator: continuous ACB with sham subcutaneous saline injection
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
Drug: Ropivacaine
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.

Drug: Saline
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.
Outcome Measures
  • Primary Outcome Measures: 1. Cumulative opioid consumption (morphine equivalents) in the first 24 hours [ Time Frame: 24 hours ]
  • Secondary Outcome Measures: 1. Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score [ Time Frame: through study completion approximately 2 days ]
  • 2. 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 ]
  • 3. 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 ]
  • 4. 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 ]
  • 5. Walk distance on POD#1 am, POD#1 pm, POD#2 [ Time Frame: through study completion approximately 2 days ]
  • 6. Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room [ Time Frame: through study completion approximately 2 days ]
  • 7. Time to oral-only opioids [ Time Frame: through study completion approximately 2 days ]
  • 8. Pain location [ Time Frame: through study completion approximately 2 days ]
  • 9. Hospital length of stay [ Time Frame: through study completion approximately 2 days ]
  • 10. Incidence of foot drop [ Time Frame: through study completion approximately 2 days ]
  • 11. Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm [ Time Frame: through study completion approximately 2 days ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Ochsner Health System

Investigators

Principal Investigator: Matthew Patterson, MD Ochsner

More Information
  • Responsible Party: Ochsner Health System
  • ClinicalTrials.gov Identifier: NCT03921034 History of Changes
  • Other Study ID Numbers: 2016.307.C
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: April 19, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: No plan
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Joint Diseases