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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

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Principal Investigator

Brian P. Chalmers, M.D.

Co-Investigators

Claude Regis
​​​​​​​Daniel Maalour, MD, MPH
Aaron Weinblatt
​​​​​​​​​​​​​​Colin Neitzke
​​​​​​​​​​​​​​Peter Sculco, MD
Michael Parides
​​​​​​​​​​​​​​Alejandro Gonzalez Della Valle, MD​​​​​​​
Kethy 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