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Clinical Trials/NCT02863120
NCT02863120
Completed
Phase 4

Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty

Texas Orthopaedics, Sports and Rehabilitation Associates1 site in 1 country63 target enrollmentJuly 2016

Overview

Phase
Phase 4
Intervention
liposomal bupivacaine
Conditions
Knee Osteoarthritis
Sponsor
Texas Orthopaedics, Sports and Rehabilitation Associates
Enrollment
63
Locations
1
Primary Endpoint
Length of stay (LOS, in days)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
December 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Texas Orthopaedics, Sports and Rehabilitation Associates
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or non-pregnant female between the ages of 18-65
  • Patients willing and able to sign the informed consent
  • Patients able to comply with follow-up requirements including self-evaluations
  • Patients requiring a primary total knee replacement
  • Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis

Exclusion Criteria

  • Revision total knee arthroplasty
  • Bilateral total knee arthroplasty
  • Patients with inflammatory arthritis
  • Patients with a body mass index (BMI) \> 40
  • Allergy to ropivacaine, bupivacaine, or other local anesthetic agents
  • Current use of opioid drugs
  • Patients with a history of total or unicompartmental reconstruction of the affected joint
  • Patients that have had a high tibial osteotomy or femoral osteotomy
  • Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels
  • Patients with a systemic or metabolic disorder leading to progressive bone deterioration

Arms & Interventions

Liposomal bupivacaine

Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants

Intervention: liposomal bupivacaine

Liposomal bupivacaine

Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants

Intervention: bupivacaine HCl

Liposomal bupivacaine

Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants

Intervention: Saline

Adductor canal and tibial nerve block

Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour

Intervention: bupivacaine HCl

Adductor canal and tibial nerve block

Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Length of stay (LOS, in days)

Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days

Time to ambulation (in hours)

Time Frame: 2-6 hours

Secondary Outcomes

  • Pain as assessed by visual analog scale (VAS) on postoperative day 3(72 hours)
  • Pain as assessed by visual analog scale (VAS) on postoperative day 2(48 hours)
  • Pain as assessed by visual analog scale (VAS) on postoperative day 1(24 hours)
  • Postoperative complications and adverse events(2 weeks)
  • Pain as assessed by visual analog scale (VAS) on postoperative day 4(96 hours)
  • Pain as assessed by visual analog scale (VAS) on postoperative day 0(6 hours)
  • Pain as assessed by visual analog scale (VAS) on postoperative day 5(120 hours)
  • Opioid consumption in oral morphine equivalents (OMEs, in milligrams)(Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.)

Study Sites (1)

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