Clinical trial

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

Name

iRIS1128_JLON

Description

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.

Trial arms

Trial start

2023-02-28

Estimated PCD

2024-02-28

Trial end

2024-02-28

Phase

Early phase I

Treatment

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

zynrelef will be administered during surgery

Arms:

primary total knee replacement + Zynrelef

Bupivacaine HCl 0.5% Injectable Solution

adductor canal block will be performed using bupivacaine before surgery

Arms:

primary total knee replacement + adductor canal block (ACB)

primary total knee replacement

Arms:

primary total knee replacement + Zynrelef, primary total knee replacement + adductor canal block (ACB)

Size

Primary endpoint

Postoperative pain

14 days

Opioid consumption

14 days

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-03-02

1 organization

2 products

2 indications

Organization

Rothman Institute Orthopaedics

Product

Indication

Indication

Product