Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| primary total knee replacement + Zynrelef | Experimental | Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef) |
|
| primary total knee replacement + adductor canal block (ACB) | Active Comparator | Patients undergoing primary total knee replacement with routine adductor canal block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution | Drug | zynrelef will be administered during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant | 14 days |
| Opioid consumption | Participants will be asked to keep a diary of how much pain medication they took after surgery | 14 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723006 | bupivacaine-meloxicam drug combination |
| D002045 | Bupivacaine |
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bupivacaine HCl 0.5% Injectable Solution | Drug | adductor canal block will be performed using bupivacaine before surgery |
|
| primary total knee replacement | Procedure | primary total knee replacement |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |