Local Anaesthetic Injection for Postoperative Pain in Inguinal Hernia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Cali Pharmaceuticals LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment called CPL-01 on patients who had hernia surgery to see which helps recovery best.

Research Team

Erol Onel

Principal Investigator

Cali Biosciences

Eligibility Criteria

This trial is for healthy adults aged 18-75 with a BMI ≤ 39 kg/m2, scheduled for inguinal hernia repair. Participants must be able to consent and complete study procedures. Women can't be pregnant or planning pregnancy; men must use birth control. Exclusions include prior herniorrhaphy, significant health issues, concurrent painful conditions requiring analgesics, certain heart problems within the last year, specific genetic disorders, liver or kidney impairment, recent malignancy or opioid use.

Inclusion Criteria

This criterion does not apply to me.

Your body mass index is less than 39.

I am between 18 and 75 years old and in good health.

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Exclusion Criteria

I have had surgery for a groin hernia before.

I have a painful condition that might need painkillers.

My kidney function is not normal.

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Treatment Details

Interventions

Local Anaesthetic Injection (Local Anaesthetic)

Trial OverviewThe trial tests the effectiveness of CPL-01 against postoperative pain following herniorrhaphy compared to a positive control (known effective treatment) and negative control (placebo or standard care). Subjects are randomly assigned to one of these groups after surgery and monitored thereafter.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CPL-01Experimental Treatment1 Intervention

Local infiltration of CPL-01

Group II: Ropivacaine HClActive Control1 Intervention

Local infiltration of Naropin

Group III: PlaceboPlacebo Group1 Intervention

Local infiltration of Saline Placebo