Multimodal Pain Management Following Primary TKA

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02369523
• Other study ID #: 74975
• Status: Terminated
• Phase: Early Phase 1
• Start date: September 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Exparel
Mixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
• Ropivacaine cocktail (PIC)
400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
• Bupivacaine
Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours. Sciatic nerve block - 0.125% bupivacaine

Locations

Country	Name	City	State
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed for the duration of hospital stay, an average of 3 days