Safety, Efficacy, and Pharmacokinetics of SKY0402 Administered as a Nerve Block in Subjects Undergoing Bunionectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: SKY0402; Bupivacaine HCl
Intervention description: Single dose of SKY0402 administered as a nerve block; Single dose of 125 mg administered as a nerve block
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative Pain; Bunionectomy; Analgesia

Summary:

      The primary objective of this study was to determine the appropriate dose of SKY0402
      administered as a nerve block for the management of postoperative pain following
      bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects were eligible for enrollment if they met the following criteria:

          1. Males and females ≥18 years of age at the Screening Visit. NOTE: Eligible females were
             postmenopausal or surgically sterile, or, if of child bearing potential, were not
             pregnant or nursing, and they agreed to not become pregnant during the study by using
             acceptable means of contraception for at least 1 month before and 1 month after
             dosing, including any of the following: hormonal contraceptives (oral, injectable,
             implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine
             device (IUD), lifestyle with a personal choice of abstinence, non-heterosexual
             lifestyle, or in a strictly monogamous relationship with a partner who has had a
             vasectomy.

          2. Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair under
             general anesthesia, with or without internal fixation.

             NOTE: For the purpose of this protocol, all surgical procedures involving osteotomy of
             the first metatarsal (significant bone resection, excision, surgical fracture, etc.)
             or fusion of the first metatarsal phalangeal joint were considered qualified
             procedures, whether or not performed specifically to repair a bunion (hallus valgus
             deformity). Surgical techniques accompanied by minimal bone excision (e.g.
             cheilectomy) or procedures limited to soft tissue repair were not eligible for this
             study.

          3. American Society of Anesthesiology (ASA) Physical Class 1 or 2.

          4. Able and willing to comply with all study visits and procedures.

          5. Capable of speaking and understanding the local language sufficiently to provide
             responses to pain assessment scales.

          6. Willing and capable of providing written informed consent.

        Exclusion Criteria:

        Subjects were excluded from the study if they met any of the following criteria:

          1. Clinically significant electrocardiogram (ECG) abnormalities at Screening or on Day 1
             (before dosing).

          2. Albumin and/or alpha 1 acid glycoprotein (AAG) below normal levels.

          3. Current or historical evidence of any clinically significant disease or condition
             that, in the opinion of the Investigator, might have increased the risk of surgery or
             complicated the subject's postoperative course.

          4. Opioid medication usage during the 7 day period preceding the administration of study
             drug.

          5. Current medical conditions that could have required treatment with analgesic
             medications in the postoperative period for pain that was not surgically related
             (e.g., rheumatoid arthritis).

          6. Body mass index >30 kg/m^2.

          7. Body weight less than 60 kilograms.

          8. History of hypersensitivity or idiosyncratic reaction to amide type local anesthetic
             agents.

          9. History of hypersensitivity, idiosyncratic reactions, and other contraindications to
             the pain control agents (opioid or non-opioid) anticipated to be used postoperatively.
             These contraindications may have included the following: angioedema and bronchospastic
             reactivity to non-steroidal anti-inflammatory drug (NSAID), peptic ulcer (active
             within the last 3 months), or hepatic or renal insufficiency.

         10. Coagulation disorders or ongoing anticoagulation treatment.

         11. Administration of an investigational drug within 30 days or 5 half lives (of
             elimination), whichever was longer, prior to study drug administration.

         12. Suspected or known history of substance abuse and/or alcoholism.