IPACK Nerve Block for Total Knee Arthroplasty
- Registration Number
- NCT03921034
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description continuous ACB with sham subcutaneous saline injection Saline 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 continuous ACB with sham subcutaneous saline injection Ropivacaine 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 continuous ACB with IPACK block Ropivacaine 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
- Primary Outcome Measures
Name Time Method Cumulative opioid consumption (morphine equivalents) in the first 24 hours 24 hours
- Secondary Outcome Measures
Name Time Method Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey through study completion approximately 2 days Time to oral-only opioids 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 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 Hospital length of stay through study completion approximately 2 days Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score 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 Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm through study completion approximately 2 days Pain location through study completion approximately 2 days Incidence of foot drop through study completion approximately 2 days