Postoperative Pain Clinical Trial
Official title:
A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Total Shoulder Arthroplasty (TSA)
Verified date | October 2023 |
Source | Heron Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 30 |
Est. completion date | July 29, 2022 |
Est. primary completion date | July 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | First Surgical Hospital | Bellaire | Texas |
United States | Legent Orthopedic Hospital | Carrollton | Texas |
United States | Center for Orthopaedic Reconstruction and Excellence | Jenks | Oklahoma |
United States | Woodland International Research Group, LLC | Little Rock | Arkansas |
United States | JBR Clinical Research | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Heron Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment-emergent adverse events (TEAEs). | Through Day 15 | ||
Secondary | Maximum concentration (Cmax) of bupivacaine and meloxicam | Through 144 hours | ||
Secondary | Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam | Through 144 hours | ||
Secondary | 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 | ||
Secondary | Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam | Through 144 hours | ||
Secondary | Apparent terminal half-life (t½) of bupivacaine and meloxicam | Through 144 hours |
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