NCT05751421

Pain Relief After PrimaryTKA

Comparing the Efficacy of a Periarticular Instillation of Extended Relief Bupivacaine and Meloxicam With Routine Adductor Canal Blockade for Pain Relief After Primary TKA

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution	zynrelef will be administered during surgery
DRUG	Bupivacaine HCl 0.5% Injectable Solution	adductor canal block will be performed using bupivacaine before surgery
PROCEDURE	primary total knee replacement	primary total knee replacement

Timeline

• Start date: 2023-02-28
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2023-03-02
• Last updated: 2023-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study