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