total knee arthroplasty (tka) study of htx-011 in an multimodal analgesic regimen (mma) regimen

Conditions: Analgesia

Summary: phase 3b, open-label single-arm study in which all subjects receive htx-011 as part of a scheduled non-opioid mma regimen.


Eligibility criteria:
inclusion criteria: * is scheduled to undergo primary unilateral tka under spinal anesthesia. * has not previously undergone tka in either knee. * has an american society of anesthesiologists (asa) physical status of i, ii, or iii. * is able to walk at least 20 feet with optional use of a 4-legged walker for balance. * female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or is at least 2 years post-menopausal; or is in a monogamous relationship with a partner who is surgically sterile; or using acceptable contraceptives. exclusion criteria: * has a planned concurrent surgical procedure. * 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. * using or expected to use factor ix complex or anti-inhibitor coagulant concentrates during the study. * has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. * has taken nsaids within 10 days prior to the scheduled surgery with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection. * 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 been administered any local anesthetic within 72 hours 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. * 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 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. * is currently undergoing treatment for hepatitis b, hepatitis c, or hiv. * has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the investigator, might interfere with study assessments. * has acquired defective color vision or acute gastrointestinal ulcers, either of which could interfere with scheduled study medications. * has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature. * has any chronic condition or disease that would compromise neurological or vascular assessments. * 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 body mass index (bmi) \>39 kg/m2.

Keywords: total knee arthroplasty postoperative pain multimodal analgesia