Herniorrhaphy for Postoperative Pain

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy

Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.

Subjects pain and rescue medication use is assessed after having received either CPL-01, placebo, or ropivacaine HCl for several days after hernia repair surgery.

Inclusion Criteria:

• Able to sign Informed Consent
• Scheduled to have inguinal hernia repair
• Be a reasonably healthy adult 18 - 75 years of age
• Body mass index ≤ 39 kg/m2
• If biologically female, not pregnant or planning to become pregnant
• If biologically male, using acceptable birth control
• Be willing and able to complete study procedures

Exclusion Criteria:

• Previously inguinal herniorrhaphy
• Concurrent painful condition that may require analgesic treatment
• History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation
• Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months
• History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
• Impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis.
• Impaired renal function (e.g., creatinine > 1.5 × ULN).
• Malignancy in the past year
• Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.