Multimodal Pain Management Following Primary TKA

Early Phase 1TerminatedNCT02369523

University of Utah84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pain

Interventions

ExparelDRUG

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

Ropivacaine cocktail (PIC)DRUG

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

BupivacaineDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Time to Discharge Readiness

Time to discharge readiness will be defined as the time from surgical stop to the time of the 2nd consecutive assessment where all criteria are fulfilled.

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

Data from ClinicalTrials.gov

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