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Completed

NCT Number: NCT03921034

IPACK Nerve Block for Total Knee Arthroplasty

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.

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Key information

Conditions

Arthropathy of Knee Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Naropin

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.

Primary outcomes

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

    Time frame: 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2019
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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