Clinical trial NCT03015532 (phase 2, status: completed)
Conditions: analgesia
ICD codes: P04.0
Drugs: htx-011, saline placebo, bupivicaine hcl, ropivacaine
SMILES: [Na+].[Cl-], CNC[C@H](O)C1=CC(O)=C(O)C=C1, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        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.