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Clinical Trials/NCT02426164
NCT02426164
Withdrawn
Phase 4

Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty

Miller Orthopedic Specialists1 site in 1 countryJune 2015

Overview

Phase
Phase 4
Intervention
Liposomal bupivacaine
Conditions
Pain, Postoperative
Sponsor
Miller Orthopedic Specialists
Locations
1
Primary Endpoint
Mean visual analog scale (VAS) pain scores
Status
Withdrawn
Last Updated
10 years ago

Overview

Brief Summary

Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
June 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial

Exclusion Criteria

  • Patients with a sensitivity to marcaine
  • Pregnant or lactating women
  • Non-English speaking individuals

Arms & Interventions

Liposomal bupivacaine

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

Intervention: Liposomal bupivacaine

bupivacaine HCl, morphine, epinephrine, methylprednisolone

Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants

Intervention: bupivacaine HCl, morphine, epinephrine, methylprednisolone

Outcomes

Primary Outcomes

Mean visual analog scale (VAS) pain scores

Time Frame: Post-operative day 2

Self-reported pain scores from 0=no pain to 10=severe pain

Pain assessment phone call

Time Frame: Post-operative day 3

Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.

Secondary Outcomes

  • Complications(Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.)

Study Sites (1)

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