Clinical trial

Periarticular Infusion With Liposomal Bupivacaine or a Ropivacaine Cocktail Versus Continuous Femoral Nerve Catheters for Multimodal Pain Management Following Primary TKA: A Randomized Controlled Trial

Name

74975

Description

The investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs. periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In addition, the investigators will compare quadriceps strength recovery over time and exploratory variables between the groups.

Trial arms

Trial start

2014-09-01

Estimated PCD

2017-04-01

Trial end

2017-04-01

Status

Terminated

Phase

Early phase I

Treatment

Exparel

Mixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.

Arms:

liposomal bupivacaine (LB) (Exparel)

Ropivacaine cocktail (PIC)

400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution

Arms:

Ropivacaine cocktail (PIC)

Bupivacaine

Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours. Sciatic nerve block - 0.125% bupivacaine

Arms:

continuous femoral nerve blocks (cFNB)

Size

Primary endpoint

Time to Discharge Readiness

Participants will be followed for the duration of hospital stay, an average of 3 days

Eligibility criteria

Inclusion Criteria: * ≥ 40 Years Old * Scheduled for Primary Total Knee Arthroplasty Exclusion Criteria: * Opiate Tolerant (≥60mg/day oral morphine/equivalent for ≥1 week) * Neuromuscular deficit affecting the lower limbs * Peripheral neuropathy * Radiculopathy/Sciatica * Known allergy or intolerance to Bupivacaine or Ropivacaine * Hepatic Disease * Renal Disease/Patients needing Dialysis * Planned unicompartmental knee replacement * Less than 90 degree of knee flexion preoperatively. * Patients who lack the capacity to consent or are unwilling to do so * At the discretion of the PI, patients who may have difficulty complying with standard of care (SOC) followup may also be excluded

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}

Updated at

2023-08-15

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product