Multimodal Pain Management Following Primary TKA

NCT02369523 | Terminated Early Phase 1 DMC

• 1 other identifier: 74975
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Primary Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

liposomal bupivacaine (LB) (Exparel)

ACTIVE COMPARATOR

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

Drug: Exparel

Ropivacaine cocktail (PIC)

ACTIVE COMPARATOR

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

Drug: Ropivacaine cocktail (PIC)

continuous femoral nerve blocks (cFNB)

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

Drug: Bupivacaine

Interventions

Exparel DRUG

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

liposomal bupivacaine (LB) (Exparel)

Ropivacaine cocktail (PIC) DRUG

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

Ropivacaine cocktail (PIC)

Bupivacaine DRUG

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

continuous femoral nerve blocks (cFNB)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 40 Years Old
• Scheduled for Primary Total Knee Arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Christopher Pelt, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 24, 2015
• Study Start: September 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

US (1)