Phase 4
Completed N=38
Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT02682498 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: 48 Hour Post-surgical Opioid Use — 5.32; 5.07 morphine equivalents
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study seeks to determine whether a new sustained-release local anesthetic solution (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after surgery will decrease opioid consumption and adverse events in opioid-tolerant patients presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study) group will use less opioid in the first 48 hours post-operatively than the control group.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 48 Hour Post-surgical Opioid Use |
5.32; 5.07 | — |
| SECONDARY Recovery Room Opioid Use |
5; 5 | — |
| SECONDARY Average Daily Opioid Use During Admission |
100; 103 | — |
| SECONDARY Average Daily Patient Pain Score |
4.75; 5.75 | — |
| SECONDARY Post-operative Complications |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Males and Females age 18+ years old having total knee arthroplasty at UCI
- Meet at least one of the following criteria "opioid tolerant":
- Taking 50mg oral morphine equivalent or more per day
- On long-acting opioids (fentanyl pathc, oxycontin, methadone, etc.)
- Being followed by a chronic pain physician
- All subjects must be free of renal or hepatic dysfunction; defined as:
- Glomerular filtration rate >60 mL/min/1.73m^2
- AST & ALT <150, total bilirubin <1.0, INR <1.3 (if not taking anticoagulants)
- No active hepatitis, no jaundice
Control group- received standard periarticular injection Research group- receives Exparel injection
Exclusion Criteria
- Allergy to local Anesthetic
- Pregnancy
- Nursing mothers
- Children<18 years of age
- Renal impairment (GFR<60 mL/min/1.73 m^2
- Hepatic impairment (active hepatitis, elevated AST or ALT, jaundice)
- Any history of ventricular arrhythmia or supraventricular tachycardia, or myocardial infarction within the last six months.
Data sourced from ClinicalTrials.gov (NCT02682498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.