Lumbar Laminectomy, Post-Operative Pain
Conditions
Keywords
postoperative pain, local anesthetic, lumbar laminectomy, lumbar decompression
Brief summary
This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.
Interventions
DRUGBupivacaine HCI without epinephrine
100 mg administered via injection into the surgical site.
DRUGHTX-011
HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.
DEVICELuer Lock Applicator
Applicator for instillation.
Sponsors
Heron Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Optional Part B will be randomized, blinded, active-controlled.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is scheduled to undergo an open 1-3 level lumbar decompression surgery with or without fixation under general anesthesia. * Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.
Exclusion criteria
* Has a contraindication of a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * Has a history of severe allergic reaction due to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use. * Has functioning intrathecal drug pump or spinal cord stimulator. * Opioid use for most days within the last 3 months. * Has initiated treatment with selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine within 1 month prior to the scheduled surgery. * Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives. * Has a history of clinically significant cardiac abnormality, coronary artery bypass graft surgery within 12 months, or suspected coagulopathy or uncontrolled anticoagulation. * Has impaired balance and is at risk of falling. * Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV. * Has undergone 3 or more surgeries within 12 months. * Has a known history of glucose-6-phosphate dehydrogenase deficiency. * Has History of liver cirrhosis, having an aspartate aminotransferase \>3 × the upper limit of normal (ULN), or having an alanine aminotransferase \>3 × ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Serious Adverse Events | From the time the subject signs the ICF through the Day 29 Visit |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Baseline through 120 hours |
| Time of occurrence of maximum concentration (Tmax) | Baseline through 120 hours |
| Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast) | Baseline through 120 hours |
| Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) | Baseline through 120 hours |
| Apparent terminal half-life (t½) | Baseline through 120 hours |
Countries
United States
Outcome results
None listed