Pain Relief After PrimaryTKA

Rothman Institute Orthopaedics

Status and phase: Invitation-only; Phase 3

Conditions: Pain, Postoperative

Treatments: Procedure: primary total knee replacement; Drug: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution; Drug: Bupivacaine HCl 0.5% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05751421

iRIS1128_JLON

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients 18 years or older
• Patients undergoing primary unilateral TKA
• Patients receiving spinal anesthesia during primary TKA
• Patients with adequate cognitive function to participate and complete questionnaires for the study

Exclusion criteria

• Patients undergoing bilateral simultaneous TKA
• Patients undergoing conversion TKA
• Patients undergoing unicompartmental knee arthroplasty
• Patients undergoing patellofemoral arthroplasty
• Patients with an allergy to NSAIDs or bupivacaine
• Patients who have a contraindication to the use of NSAIDs
• Patients who are using chronic anticoagulation, precluding them from using NSAIDs
• Patients with a history or diagnosis of chronic pain syndrome or complex regional pain syndrome
• Patients who are determined to be in severe pain from other concomitant conditions
• Patients with chronic opioid use disorder, defined as patients who are taking more than 20 mg/day morphine milligram equivalents for 30 days consecutively in the 3 months prior to surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

primary total knee replacement + Zynrelef

Experimental group

Description:

Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef)

Treatment:

Procedure: primary total knee replacement

Drug: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution

primary total knee replacement + adductor canal block (ACB)

Active Comparator group

Description:

Patients undergoing primary total knee replacement with routine adductor canal block

Treatment:

Procedure: primary total knee replacement

Drug: Bupivacaine HCl 0.5% Injectable Solution