Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj
- Conditions
- Arthroplasty, Replacement, Knee
- Interventions
- Drug: (Bupivacaine Liposome Injectable Suspension)Drug: Standard Preparation
- Registration Number
- NCT02682498
- Lead Sponsor
- University of California, Irvine
- Brief 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.
- Detailed Description
Opioids have been prescribed with increasing frequency for non-acute, non-cancer pain in the last 15 years. Because of this, opioid tolerance in the general population has grown markedly, and opioid tolerant patients can be especially difficult to manage in the perioperative period. In general, they require much higher doses of opioids to obtain similar levels of pain-control compared to opioid-naïve patients and are susceptible to respiratory depression and other adverse events. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EXPAREL® Bupivacaine Liposome Suspension (Bupivacaine Liposome Injectable Suspension) Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours. Standard periarticular joint injection Standard Preparation A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.
- Primary Outcome Measures
Name Time Method 48 Hour Post-surgical Opioid Use 48 hours A comparison of group means between the control group and study group with regards to 48 hour opioid use.
- Secondary Outcome Measures
Name Time Method Average Daily Patient Pain Score Up to 48 hours Examining the average daily patient pain score in comparison of standard knee injection post-operatively. The measure is the Visual-Analog-Scale (VAS) for subjective pain reporting. The minimum 0 (no pain) and the maximum is 10 (worst pain imagineable). There is only one measure in the scale (i.e. there are no subscales). Lower scores on the VAS scale equate to less pain and are therefore desirable.
Average Daily Opioid Use During Admission Up to 48 hours Opioid use will be monitored daily from the time of admission in comparison of standard knee injection post-operatively.
Recovery Room Opioid Use Up to 48 hours Post anesthesia care unit (recovery room) opioid use in total mg morphine IV equivalent in comparison of standard knee injection post-operatively.
Post-operative Complications Up to 1 month Examining the post-operative complication in comparison of standard knee injection post-operatively.
Trial Locations
- Locations (1)
UC Irvine Medical Center
🇺🇸Orange, California, United States