Pain, Postoperative
Conditions
Brief 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.
Interventions
DRUGZynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution
zynrelef will be administered during surgery
adductor canal block will be performed using bupivacaine before surgery
PROCEDUREprimary total knee replacement
primary total knee replacement
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 14 days | This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant |
| Opioid consumption | 14 days | Participants will be asked to keep a diary of how much pain medication they took after surgery |
Countries
United States
Outcome results
None listed