Anesthesia, Arthropathy of Knee
Conditions
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.
Interventions
DRUGRopivacaine
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.
DRUGSaline
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.
Sponsors
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative opioid consumption (morphine equivalents) in the first 24 hours | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of foot drop | 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 |
| Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey | through study completion approximately 2 days |
| Hospital length of stay | 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 |
| 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 |
| Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm | through study completion approximately 2 days |
Outcome results
None listed