Overview

This trial is active, not recruiting.

Condition pain
Treatments exparel, ropivacaine cocktail (pic), bupivacaine
Sponsor University of Utah
Start date September 2014
End date September 2017
Trial size 375 participants
Trial identifier NCT02369523, 74975

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Mixture of 50 milliliters (mL) of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
exparel
Mixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
(Active Comparator)
400 milligrams (mg) Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
ropivacaine cocktail (pic)
400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
(Active Comparator)
Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours. Sciatic nerve block - 0.125% bupivacaine
bupivacaine
Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours. Sciatic nerve block - 0.125% bupivacaine

Primary Outcomes

Measure
Time to Discharge Readiness
time frame: Participants will be followed for the duration of hospital stay, an average of 3 days

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title 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
Principal investigator Christopher Pelt, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Utah.