Herniorrhaphy for Postoperative Pain

Cali Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Hernia, Inguinal

Treatments: Drug: local anaesthetic injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05813847

CPL-01-301

Details and patient eligibility

About

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

Enrollment: 504 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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504 participants in 3 patient groups, including a placebo group

CPL-01

Experimental group

Description:

Local infiltration of CPL-01

Treatment:

Drug: local anaesthetic injection

Ropivacaine HCl

Active Comparator group

Description:

Local infiltration of Naropin

Treatment:

Drug: local anaesthetic injection

Placebo

Placebo Comparator group

Description:

Local infiltration of Saline Placebo

Treatment:

Drug: local anaesthetic injection