Prospective Randomized Trial of Zynrelef on Postoperative Pain and Opioid Utilization after Total Knee Arthroplasty
IRB Number: 2022-2542
March 20, 2024
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Principal Investigator
Co-Investigators
- Claude Regis
- Daniel B. Maalouf, MD, MPH
- Aaron Weinblatt
- Colin Neitzke
- Peter K. Sculco, MD
- Michael Parides
- Alejandro Gonzalez Della Valle, MD
- Kethy M. Jules-Elysee, MD
- Felix Oettl
- Sonia Chandi
Summary
This trial will look at whether intraoperative use of Zynrelef results in improved pain control postoperatively compared to patients who receive the standard protocol for pain management at HSS after unilateral primary total knee arthroplasty (TKA). There will be 270 patients enrolled that will be randomized into one of two treatment arms (arms 1: standard protocol versus arm 2: standard protocol + Zynrelef). The patients will be enrolled pre-operatively and be followed for up to 2 weeks postoperatively.
Inclusion/Exclusion Criteria
Inclusion
- Patients undergoing elective primary unilateral total knee arthroplasty for a diagnosis of OA within the affected joint
- Patient 18 years or older
- Patient will intraoperatively receive Spinal anesthesia
- Patient will receive adductor canal block (ADB) + interspace between the popliteal artery and the posterior knee capsule (iPACK) block for postoperative pain
- Could receive PAI or Zynrelef
- Patients to undergo TKA with cemented fixation
Exclusion
- Contraindication to regional anesthesia or NSAIDs
- Use of general anesthesia
- Preoperative systemic steroid use in the past 6 months
- Preexisting diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency (e.g., rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type 1 diabetes)
- History of open surgery in the knee (except arthroscopic surgery)
- Post-traumatic arthritis
- Hx of skeletal dysplasia.
- Need for removal of hardware during the same procedure.
- Coronal deformity > 20 degrees or flexion contracture > 15 degrees.
- Use of cementless components
- Non-resurfaced patella
- Patient has an active infection
- Chronic pain medication or consultation with pain management within 6 months of surgical date
- Pregnant women
- Patient is involved in other interventional research study
- BMI ≥ 40
Contact Information
Brian P. Chalmers, MD
chalmersb@hss.edu
212.606.1975
Aaron Weinblatt, Research Aide
weinblatta@hss.edu
646.797.8902