Analgesia
Conditions
Keywords
postoperative pain, total shoulder arthroplasty, abdominoplasty, multimodal analgesia
Brief summary
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.
Interventions
DRUGBupivacaine Hydrochloride
100 mg
DRUGHTX-011
400 mg
DEVICELuer lock applicator
Applicator for instillation
DRUGIbuprofen
400 mg
DRUGAcetaminophen
1 g
Sponsors
Heron Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
In each cohort, 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 (TSA) or abdominoplasty.
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. * Had undergone prior abdominoplasty or major abdominal wall surgery.
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