A Phase 4 interventional study of Periarticular Injection and Adductor Canal Block in Osteoarthritis (OA) of the Knee, sponsored by Henry Ford Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment
Participants are being invited to take part in a research study about pain control after total knee replacement surgery (also called total knee arthroplasty or TKA). The goal of this study is to see if a new long-acting medication, called Zynrelef, can control pain after surgery as well as or better than two other common pain treatments - a nerve block or a standard injection into the knee during surgery.
Knee replacement is done to reduce pain and improve movement in people with severe knee arthritis. While the surgery can be very successful, pain during the first few days after surgery can make recovery harder. Many patients need strong opioid pain medicines, but these medicines can have side effects and may lead to dependence. The investigators want to find ways to control pain that reduce or even remove the need for opioids.
If participants join this study, they will be randomly placed (like flipping a coin) into one of three groups:
Standard injection (PAI) - a mix of medicines injected into the knee during surgery.
Zynrelef - a new long-acting medicine put directly into the knee during surgery, along with a smaller dose of the standard injection.
Nerve block (ACB) - medicine given near a nerve in the leg before surgery to block pain.
All participants will get the same medicines before and after surgery, follow the same physical therapy program, and have the same follow-up visits. Participants will be asked to record their pain scores and the pain medicines they take for several weeks after surgery.
The risks of joining are small and similar to those of routine care. All three pain control methods are already used in regular knee replacement surgery. Possible side effects may include temporary numbness, weakness, or soreness from the injections, and the usual surgical risks such as infection.
Participants may benefit from better pain control, less need for opioids, and a smoother recovery. The results from this study may also help future patients have safer and more comfortable knee replacements.
Taking part is voluntary. Participants can leave the study at any time without affecting their medical care.
Exclusion Criteria:
Study group I (standard PAI) will receive an intraoperative periarticular injection consisting of 300mg of 0.5% ropivacaine with 1mg epinephrine and 30mg ketorolac in sodium chloride 0.9% diluted to a volume of 120ml.
Drug: Periarticular Injection
(adductor canal block) will receive an adductor canal block in the preoperative bay.
Drug: Adductor Canal Block
will receive the extended-release bupivacaine injected into the effective knee joint space prior to closure, combined with an abbreviated PAI of half dose (150mg ropivacaine) to act as a bridge per standard recommendation.
Drug: Bupivacaine-Meloxicam
Study group I (standard PAI) will receive an intraoperative periarticular injection consisting of 300mg of 0.5% ropivacaine with 1mg epinephrine and 30mg ketorolac in sodium chloride 0.9% diluted to a volume of 120ml.
Also known as: Periarticular Injection (PAI)
Patients randomized to the adductor canal block (ACB) arm will receive a preoperative ACB administered by an anesthesia provider prior to total knee arthroplasty, with additional ropivacaine administered to the posterior capsule per standard protocol.
Also known as: Saphenous Nerve Block, Subsartorial Block
will receive the extended-release bupivacaine injected into the effective knee joint space prior to closure, combined with an abbreviated PAI of half dose (150mg ropivacaine) to act as a bridge per standard recommendation.
Also known as: Zynrelef
Postoperative Pain Score Assessed Using the Numeric Rating Scale (NRS)
Postoperative pain will be assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain outcomes. Pain scores will be recorded daily by participants from postoperative day 0 through postoperative day 5.
Time frame: Postoperative Day 0-Postoperative Day 5
Emergency Department Visits
Any unplanned emergency department visit occurring within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Time frame: 90 days post-op
Mortality
Any cause of death occurring within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Time frame: 90 days post-op
Postoperative Unplanned Readmission
Any unplanned hospital readmission occurring within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Time frame: 90 days post-op
Return to Operating Room
Any unplanned return to the operating room for any reason within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Time frame: 90 days post-op
Number of Participants with Hardware Failure of Implanted Prosthetic Components
Any mechanical failure of implanted prosthetic components, including loosening, breakage, or malposition, occurring within 90 days of total knee arthroplasty, as identified through chart review and imaging.
Time frame: 90 days post-op
Number of Participants with Periprosthetic or Perioperative Fracture
Any periprosthetic or perioperative fracture occurring within 90 days of total knee arthroplasty, as identified through chart review and imaging.
Time frame: 90 days post-op
Number of Participants with Postoperative Dislocation of the Prosthetic Joint
Any dislocation of the prosthetic joint occurring within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Time frame: 90 days post-op
Number of Participants with Periprosthetic Joint Infection (PJI)
Any prosthetic joint infection diagnosed within 90 days of total knee arthroplasty per established diagnostic criteria, as identified through chart review, laboratory findings, and the electronic medical record.
Time frame: 90 days post-op
Number of Participants with Postoperative Hematoma
Any hematoma formation at the surgical site requiring clinical intervention or documentation within 90 days of total knee arthroplasty, as identified through chart review and the electronic medical record.
Time frame: 90 days post-op
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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