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IPACK Nerve Block for Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03921034
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Patterson, Ochsner Health System

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 Intervention/treatment Phase
Arthropathy of Knee Anesthesia Drug: Ropivacaine Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care 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.
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 17, 2016
Actual Primary Completion Date : January 23, 2018
Actual Study Completion Date : January 23, 2018

Resource links provided by the National Library of Medicine


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.
Other Name: Naropin

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.
Other Name: Naropin

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.




Primary Outcome Measures :
  1. Cumulative opioid consumption (morphine equivalents) in the first 24 hours [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Walk distance on POD#1 am, POD#1 pm, POD#2 [ Time Frame: through study completion approximately 2 days ]
  5. Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room [ Time Frame: through study completion approximately 2 days ]
  6. Time to oral-only opioids [ Time Frame: through study completion approximately 2 days ]
  7. Pain location [ Time Frame: through study completion approximately 2 days ]
  8. Hospital length of stay [ Time Frame: through study completion approximately 2 days ]
  9. Incidence of foot drop [ Time Frame: through study completion approximately 2 days ]
  10. Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm [ Time Frame: through study completion approximately 2 days ]
  11. Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score [ Time Frame: through study completion approximately 2 days ]


Information from the National Library of Medicine

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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

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): NCT03921034


Sponsors and Collaborators
Ochsner Health System
Investigators
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Principal Investigator: Matthew Patterson, MD Ochsner
  Study Documents (Full-Text)

Documents provided by Matthew Patterson, Ochsner Health System:
Informed Consent Form  [PDF] November 17, 2016


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Responsible Party: Matthew Patterson, Principal Investigator, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03921034    
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

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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
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents