Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Heron Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia).
Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study; sterile, or using acceptable contraceptives.
You may not be if
Had contralateral foot bunionectomy in the past 3 months.
Has a planned concurrent surgical procedure.
Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
Has received or is taking a contraindicated or prohibited medications.
Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months.
Has a history of coronary artery bypass graft surgery within 12 months.
Has a history of known or suspected coagulopathy.
As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
Has uncontrolled anxiety, psychiatric, or neurological disorder.
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.
Has a known history of glucose-6-phosphate dehydrogenase deficiency.
Has any of the following laboratory abnormalities during Screening (1 retest permitted):
* Severe liver function impairment.
* Severe kidney function impairment.
* Platelet count \<100,000/μL, hemoglobin \<12 g/dL, or hematocrit \<35%.
Has a body mass index (BMI) \>39 kg/m2.
Clareo Health | Dose-Escalation Study of HTX-034 Following Bunionectomy
