bunionectomy study for postoperative analgesia (epoch 1)

Conditions: Postoperative Pain

Summary: this is a phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of htx 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.


Eligibility criteria:
inclusion criteria: * is scheduled to undergo a primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia. * has an american society of anesthesiologists 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. exclusion criteria: * has had a contralateral foot bunionectomy in the past 3 months. * has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral procedures on the surgical foot). * has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. * has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. * has taken any nsaids within at least 10 days prior to the scheduled surgery. * has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting). * has been administered bupivacaine within 5 days prior to the scheduled surgery. * has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control. * has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. * has a medical condition such that, in the opinion of the investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. * 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 a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. note: subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. subjects taking medical marijuana are not allowed to participate in the study. * received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives. * has undergone 3 or more surgeries within 12 months. * has a body mass index (bmi) \>39 kg/m2.

Keywords: bunion bunionectomy bunion surgery postoperative pain