Multimodal Pain Management Following Primary TKA

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

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02369523

Enrollment

Registered

2015-02-24

Start date

2014-09-30

Completion date

2017-04-30

Last updated

2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Primary Total Knee Arthroplasty

Brief 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.

Interventions

DRUGExparel

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

DRUGRopivacaine cocktail (PIC)

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

DRUGBupivacaine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026