Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery
Postoperative Pain
About this trial
This is an interventional other trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following criteria to be considered eligible to participate in the study:
- Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a long acting local anesthetic as per the anesthesia protocol
- Be American Society of Anesthesiology (ASA) physical Class I or II
- Subjects 18 years of age or older
- Have clinical laboratory values that are within normal limits (WNL); subjects with AST/ALT < 3 x ULN, and/or creatinine < 2 x ULN are acceptable.
- Have a body mass index ≤ 30 kg/m2
Female subjects are eligible only if all of the following apply:
- Not pregnant (female subject of child bearing potential must have a negative serum pregnancy tests at screening and negative urine pregnancy test before surgery)
- Not lactating
- Not planning to become pregnant during the study
- Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study
- Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study
- Does NOT have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
- Must be able to understand study procedures and be willing to comply and give informed consent for the conduct of all study procedures, using an IRB approved consent
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from participating in the study:
- Have a contraindication or be allergic to any medication to be used during the trial period
- Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of post-operative pain
- Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants
- Currently taking analgesics for a chronically painful condition, or has taken long acting opioids within 3 days of surgery, or taken any opioids within 24 hours of surgery
- Previous abdominal surgery, as determined by the investigator, that would preclude participation in the study
- Subjects that require liposuction as part of the abdominoplasty procedure in Part A of the protocol
- Subjects that are to have ancillary procedures performed during the abdominoplasty surgery that are unrelated to the abdominal area (breast reduction, breast augmentation, etc.)
- Subjects unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the scheduled abdominoplasty procedure and before dosing with investigational product
- Subjects taking the following medications; anticonvulsants, sedatives (including benzodiazepines) corticosteroids (by any means of administration), nonsteroidal anti-inflammatory drugs (NSAIDS) within 24 hours of study drug dosing, morphine, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin-norepinephrine reuptake inhibitors (SNRIs). Gabapentin and pregabalin are not permitted
- Have a known or suspected history of alcohol or drug abuse
- Have positive results on the alcohol breath test indicative of alcohol abuse or urine drug screen indicative of illicit drug use (unless results can be explained by a current prescription or acceptable over-the-counter medication at screening as determined by the investigator). The urine drug screen prior to surgery must be negative
- Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator
- Have received any investigational product within 30 days before start of study
- Have previously received HTX-011 in clinical trials
- Experiences a clinically significant event during surgery prior to the administration of the investigational product (e.g., excessive bleeding, hemodynamic instability) that would render the subject medically unstable, complicate their post-surgical course, or significantly increase the risk of study drug administration as per the judgment of the investigator. This will result in the subject being reported as randomized, not treated.
- Subjects with sleep apnea or are on home continuous positive airway pressure (CPAP)
- Subjects who are receiving oxygen therapy at the time of screening
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Part A, Cohort A: HTX-011A
Parts A and B, Cohort B: Saline Placebo
Part A, Cohort C: HTX-011B
Part A, Cohort D: HTX-011B
Part A, Cohort E: HTX-011B
Part A, Cohort F: HTX-011B
Part B, Cohort A: HTX-002
Part C, Cohort A: HTX-011B
Part C, Cohort B: HTX-011B
Part C, Cohort C: HTX-011B
Part C, Cohort D: Bupivacaine HCI
Part C, Cohort E: Saline Placebo
HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection
Saline placebo via injection
HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection
HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection
HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination
HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection
HTX-002, 400 mg via combination
HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation
HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination
HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination
Bupivacaine HCl, 100 mg via injection
Saline placebo via injection