Multimodal Analgesia, Postoperative Pain, Total Shoulder Arthroplasty
Conditions
Brief summary
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).
Interventions
DRUGHTX-011
400 mg
DRUGBupivacaine Hydrochloride
100 mg
DRUGIbuprofen
400 mg
DRUGAcetaminophen
1 g
DEVICELuer lock applicator
Applicator for instillation
Sponsors
Heron Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Subjects will be randomized in a 2:1 ratio to HTX-011 or bupivacaine HCl, respectively. All subjects will receive a scheduled postoperative non opioid multimodal analgesic (MMA) regimen.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III. * Is scheduled to undergo a unilateral Total Shoulder Arthroplasty.
Exclusion criteria
* Is undergoing a revision surgery. * Has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs, acetaminophen, oxycodone, morphine, or hydromorphone. * History of severe allergic reaction to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use. * Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection. * Opioid use for most days within the last 3 months prior to Screening in the opinion of the Investigator. * Has been administered immediate-release bupivacaine HCl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery. * Has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors. * Has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer). * Has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years. * Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection. * Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * Has undergone 3 or more surgeries within 12 months, other than for diagnostic procedures (eg, colonoscopy). * Has a body mass index (BMI) \>40 kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs). | Through Day 15 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) of bupivacaine and meloxicam | Through 144 hours |
| Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam | Through 144 hours |
| Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration (AUClast) of bupivacaine and meloxicam | Through 144 hours |
| Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam | Through 144 hours |
| Apparent terminal half-life (t½) of bupivacaine and meloxicam | Through 144 hours |
Countries
United States
Outcome results
None listed