What side effects are associated with this type of intervention?

The most common treatment for inguinal hernia is surgical repair, known as herniorrhaphy. Postoperative pain management often involves analgesics. Common side effects of surgical repair include pain, infection, and recurrence of the hernia. Pain management with analgesics can lead to side effects such as nausea, constipation, dizziness, and, in some cases, dependency on pain medication. If antibiotics are used to prevent infection, potential side effects include gastrointestinal disturbances and allergic reactions. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for inguinal hernia, primarily focusing on surgical interventions and postoperative care. Analgesics like acetaminophen and NSAIDs (e.g., ibuprofen) are commonly used for pain management post-surgery. Antibiotics may be administered prophylactically to prevent infection. Additionally, certain medications that promote healing and reduce inflammation, such as corticosteroids, may be used in specific cases. While specific drugs similar to CPL-01 are not detailed, these categories broadly cover the typical pharmacological approaches in inguinal hernia treatment.

What other types of research exist?

Promising novel alternatives for inguinal hernia patients in 2024 include the Onstep technique, which has shown favorable outcomes in terms of postoperative pain and recovery time compared to the traditional Lichtenstein repair. Additionally, the use of triclosan-coated sutures has been effective in reducing surgical site infections, which can be beneficial in hernia repair surgeries. For pain management, gabapentinoids like pregabalin and gabapentin are being explored for their efficacy in reducing chronic postoperative pain. These alternatives offer advancements in both surgical technique and postoperative care.

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Local Anaesthetic

Local Anaesthetic Injection for Postoperative Pain in Inguinal Hernia

Phase 3

Recruiting

Research Sponsored by Cali Pharmaceuticals LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

others

Scheduled to have inguinal hernia repair

Must not have

Previously inguinal herniorrhaphy

Impaired renal function (e.g., creatinine > 1.5 × ULN)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Pivotal Trial

Summary

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

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects from local anaesthetic injections like CPL-01 may include temporary numbness around the injection site, bruising or bleeding at the injection spot, allergic reactions ranging from mild irritation to more severe responses depending on individual sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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This criterion does not apply to me.

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I am scheduled for inguinal hernia surgery.

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I am using birth control methods approved by my doctor.

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I am not pregnant nor planning to become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery for a groin hernia before.

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My kidney function is not normal.

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I have been diagnosed with cancer within the last year.

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My liver isn't working well (e.g., high ALT or bilirubin levels).

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I have a history of malignant hyperthermia or G6PD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain control

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

local anaesthetic injection

2018

Completed Phase 4

~610

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for inguinal hernia primarily involve surgical repair, such as open herniorrhaphy or laparoscopic surgery, which work by repositioning the herniated tissue and reinforcing the abdominal wall, often with mesh implants. This is crucial for preventing complications like tissue strangulation. Postoperative pain management, which may include analgesics, anti-inflammatory medications, or local anesthetics, helps reduce pain and inflammation, facilitating quicker recovery and improving patient comfort. Understanding these mechanisms is important for patients to appreciate how these treatments address both the structural and symptomatic aspects of inguinal hernia.