A Phase 3 interventional study of Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution and Bupivacaine HCl 0.5% Injectable Solution in Pain, Postoperative, sponsored by Rothman Institute Orthopaedics. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by Rothman Institute Orthopaedics · Phase 3, Interventional, and Treatment
While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. Traditionally, opioid medications have been used to control postoperative pain. However, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly. In an effort to overcome this, opioid-sparing multimodal analgesia (MMA) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (NSAIDs), acetaminophen, regional nerve blocks, and local anesthesia.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Rothman Institute Orthopaedics is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef)
Drug: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution · Procedure: primary total knee replacement
Patients undergoing primary total knee replacement with routine adductor canal block
Drug: Bupivacaine HCl 0.5% Injectable Solution · Procedure: primary total knee replacement
zynrelef will be administered during surgery
adductor canal block will be performed using bupivacaine before surgery
primary total knee replacement
Postoperative pain
This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant
Time frame: 14 days
Opioid consumption
Participants will be asked to keep a diary of how much pain medication they took after surgery
Time frame: 14 days
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Rothman Institute Orthopaedics