Herniorrhaphy for Postoperative Pain (NCT05813847) | Clinical Trial Compass
CompletedPhase 3
Herniorrhaphy for Postoperative Pain
United States518 participantsStarted 2023-04-18
Plain-language summary
Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.