Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled,
 multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to
 evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered
 via infiltration to the surgical site.
Inclusion Criteria:

 -  Is scheduled to undergo primary unilateral TKA under general anesthesia.

 -  Has not previously undergone TKA in either knee.

 -  Has an American Society of Anesthesiologists Physical Status of I, II, or III.

 -  Is able to demonstrate motor function by performing a timed 20-meter walk unassisted,
 but with the 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 using acceptable contraceptives.

 Exclusion Criteria:

 -  Has a planned concurrent surgical procedure (eg, bilateral TKA).

 -  Has a pre-existing concurrent acute or chronic painful/restrictive physical condition
 that may require analgesic treatment in the postoperative period for pain.

 -  Has a contraindication or a known or suspected history of hypersensitivity or
 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 NSAIDs within 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.

 -  Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active
 Hepatitis C.

 -  Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere
 with study assessments.

 -  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 non-metastatic 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.

 -  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) >38 kg/m2.