CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
periarticular bupivicaine and liposomal bupivicainedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02276040
NCT02276040N/ACompleted
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Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty

OrthoCarolina Research Institute, Inc.·observational·Posted Oct 27, 2014·Updated Nov 30, 2017

In Brief

An observational study evaluating periarticular bupivicaine and liposomal bupivicaine for Knee Pain Arthritis. Completed, enrolled 26 participants across 4 sites.

Detailed Summary

The purpose of this study is to quantify the total blood serum levels of bupivacaine in OrthoPAT® collected blood 2 hours and 5 hours postoperatively. Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or undetectable levels of bupivacaine hydrochloride (HCL). Reinfusion of collected blood from the OrthoPAT® device when used in conjunction with periarticular bupivicaine injections will not pose a bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Pain Arthritis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 27, 2014
Enrollment StartOct 1, 2014
Primary CompletionJun 1, 2015
Study CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.7 years ago

Interventions

periarticular bupivicaine and liposomal bupivicainedrug

Participants will receive Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel is administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine).