NCT03921034 - IPACK Nerve Block for Total Knee Arthroplasty | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

72

Conditions

Arthropathy of Knee Anesthesia

Interventions

RopivacaineDRUG

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.

SalineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey