A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV

Inclusion Criteria: * Informed consent: Signed informed consent form obtained at screening prior to any procedures being performed. * Gender: Male or non-pregnant and non-lactating female. * Age: 18 years or older at time of consent. * Foot condition: Primary unilateral first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. * Pain Severity: Presence of moderate or severe pain on a categorical pain intensity scale at Baseline * Pain Confirmation: On the 0-10 numerical pain intensity scale at Baseline. * Diary Completion: Be willing and able to record safety and efficacy ratings in the Diaries. * Safe Transportation Home: Patient must have arrangements for transportation home from the research center accompanied by a responsible adult. Exclusion Criteria: * Medical condition: Presence of a serious medical condition, intolerance to NSAIDs, or any other medical condition which, in the opinion of the Investigator, makes the patient unsuitable for participation. * Infection: Acute infection of the surgical site at the time of surgery that could confound post-surgical evaluation. * Drug Allergy: History of hypersensitivity to an opioid drug (such as hydrocodone), promethazine, acetaminophen, NSAID (such as ibuprofen or aspirin), midazolam, propofol, mepivacaine, ropivacaine or ketorolac. * Confounding and Contraindicated Drugs: Other than protocol-permitted medications administered pre-operatively or during surgery: use within 14…