Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2024-04-18

Brief Summary

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The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.

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Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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HTX-011 Treatment Group

Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia

Group Type EXPERIMENTAL

HTX-011

Intervention Type DRUG

Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution

Standard Block Control Group

Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia

Group Type ACTIVE_COMPARATOR

ropivacaine , epinephrine , ketorolac diluted in sodium chloride

Intervention Type DRUG

Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride

Interventions

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HTX-011

Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution

Intervention Type DRUG

ropivacaine , epinephrine , ketorolac diluted in sodium chloride

Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride

Intervention Type DRUG

Other Intervention Names

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Zynrelef Mayo Clinic standard arthroplasty block

Eligibility Criteria

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Inclusion Criteria

* ASA classification I to III, older than or equal to 18 years old.
* Presenting for primary total knee replacement for degenerative joint disease.
* Patient capable of providing their own informed consent.

Exclusion Criteria

* Vulnerable study populations including prisoners.
* Patients with a contralateral total knee arthroplasty \< 2 years prior to the index procedure.
* Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative.
* Patients unable to provide their own informed consent.
* Pregnancy.
* Patients with documented chronic pain syndromes.
* Patients with a history of prolonged daily opioids (more than 1 month) with an oral morphine equivalent of greater than 5mg/day.
* BMI \> 45 kg/m\^2.
* Allergies to any component of the study medications, including specific history of type 1 hypersensitivities to any NSAID.
* Patients with impaired cognitive function.
* Major systemic illnesses such as severe renal (estimated glomerular filtration rate less than 50ml/min), coronary artery disease requiring a bypass graft (CABG), other cardiac problems including congestive heart failure (CHF New York Heart Association class III to IV), or severe hepatic disorders defined as current or past diagnosis of acute/subacute liver necrosis, acute hepatic failure, chronic liver disease, liver abscess, hepatic coma, hepatorenal syndrome and other disorders of the liver.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No