Knee Arthroplasty, Total, Osteoarthritis (OA), Osteoarthritis (OA) of the Knee, Pain After Surgery, Periarticular Block
Conditions
Keywords
Zynrelef
Brief summary
Prospective Cohort of patients who are scheduled for a Robot Assisted Total Knee Arthroplasty (RATKA). A prospective survey of patient reported outcome measures (Numeric Rating Scale) will be obtained postoperatively of 72 hours, as well as at the postoperative opioid consumption after 72 hours.
Detailed description
Opioid use is a well-discussed issue in the United States among orthopedic surgeons, as while these drugs are helpful and necessary, they pose the risk of addiction and ultimately should be used as sparingly as possible. By taking a multimodal approach to pain management, this can be successfully achieved. Periarticular injections are currently used to achieve this goal, and 2021 a bupivacaine-meloxicam extended-release periarticular injection (Zynrelef) was introduced and is regularly implemented into RATKAs. Randomized clinical trials found that Zynrelef's use in traditional total knee arthroplasties (TKA) was just as effective as standard periarticular injections in reducing opioid use and pain, but whether Zynrelef works just as well if not better in RATKA is not yet established. Objectives: (primary and important secondary objectives) To evaluate the improvement in pain and use of opioids of a patient who received Zynrelef after undergoing RATKA compared to the traditional periarticular injections commonly used. The secondary objective will be documentation of the patient's use of other oral (over-the-counter) OTC pain relievers, such as acetaminophen or NSAIDs (non-steroidal anti inflammatory drugs). Study Design: Prospective Cohort Study (double arm) Setting/Participants: Patients who have undergone a standard of care RATKA at any Allegheny Health Network facility who consent to filling out a survey addressing their reported outcomes. Study Interventions and Measures: Patients will be evaluated with the Numeric Rating Scale (NRS) on postoperative days 1-3. Patients will be given paper forms which will be collected by the physicians at their next postoperative visit. A retrospective review of Epic Electronic Medical Records (EMR) will also be conducted to describe basic demographic characteristics.
Interventions
COMBINATION_PRODUCTbupivacaine-meloxicam (extended release)
These surgeons will be using Zynrelef (bupivacaine-meloxicam extended release) as a form of periarticular analgesia.
DRUGBupivacaine
These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.
DRUGKetorolac
These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.
DRUGLidocaine (drug)
These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Males or females aged 18-89 years Diagnosed with knee osteoarthritis requiring surgical intervention Indicated for unilateral RATKA
Exclusion criteria
Pediatric, pregnant, or incarcerated patients BMI of more than 45 kg/m2 Prolonged opioid use history of \>5 mg/day for \>1 month History of contralateral TKA \<2 years prior to the index TKA Type 1 Hypersensitivity to NSAIDs or local anesthetics Diagnosis of severe renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of opioid medications used (measured in morphine milligrams equivalents) | From completion of surgery to 3 days post-op | Self-report of opioid medications |
| Patient reported outcome measure (Numeric Rating Scale) | From completion of surgery to 3 days post-op | Self-report of pain using numeric scale. Title: Numeric Rating Scale; Ranges from 0 to 10, where 10 is maximal pain and 0 is no pain at all. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of oral Over-the-counter (OTC) pain reliever medications used | From completion of surgery to 3 days post-operation | Self-report of Over-the-counter (OTC) pain relievers |
| Complications and Adverse Events | From completion of surgery to 3 days post-op | Report of adverse events |
Contacts
CONTACTObinna Ajah, MD
PRINCIPAL_INVESTIGATORAndrew Waligora, MD
Allegheny Health Network
Outcome results
None listed