Multimodal Pain Management Following Primary TKA

Early Phase 1

Terminated

• Conditions: Pain
• Interventions: Drug: Exparel; Drug: Ropivacaine cocktail (PIC); Drug: Bupivacaine

• Registration Number: NCT02369523
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-24
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liposomal bupivacaine (LB) (Exparel)	Exparel	Mixture of 50 milliliters (mL) of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
Ropivacaine cocktail (PIC)	Ropivacaine cocktail (PIC)	400 milligrams (mg) Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
continuous femoral nerve blocks (cFNB)	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Utah Orthopaedic Center; 🇺🇸 Salt Lake City, Utah, United States