Postoperative Pain Outcomes After Use of Bupivacaine-Meloxicam Extended-Release Solution in Robot Assisted Total Knee Arthroplasty: A Prospective Study
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Enrollment
- 150
- Primary Endpoint
- Patient reported outcome measure (Numeric Rating Scale)
Overview
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 OTC pain relievers, such as acetaminophen or NSAIDs.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Zynrelef
Periarticular injection of bupivacaine-meloxicam extended release
Intervention: bupivacaine-meloxicam (extended release) (Combination Product)
Control
Periarticular injection of bupivacaine, ketorolac, and lidocaine
Intervention: bupivacaine + ketorolac + lidocaine (Combination Product)
Outcomes
Primary Outcomes
Patient reported outcome measure (Numeric Rating Scale)
Time Frame: From completion of surgery to 3 days post-op
Self-report of pain using numeric scale
Amount of opioid medications used (measured in morphine milligrams equivalents)
Time Frame: From completion of surgery to 3 days post-op
Self-report of opioid medications
Secondary Outcomes
- Complications and Adverse Events(From completion of surgery to 3 days post-op)
- Amount of oral OTC pain reliever medications used(From completion of surgery to 3 days post-op)
Investigators
Andrew Waligora
Physician
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)