Pain Relief After PrimaryTKA

Rothman Institute Orthopaedics60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain, Postoperative

Interventions

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

zynrelef will be administered during surgery

Bupivacaine HCl 0.5% Injectable SolutionDRUG

adductor canal block will be performed using bupivacaine before surgery

primary total knee replacementPROCEDURE

primary total knee replacement

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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