Local Anaesthetic Injection for Postoperative Pain in Inguinal Hernia

Overseen By Erol Onel

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cali Pharmaceuticals LLC

Must not be taking: Opioids

Disqualifiers: Painful condition, Arrhythmia, Liver disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

504 Participants Needed

What You Need to Know Before You Apply

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.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are using opioids daily, you may not be eligible to participate.

Is local anaesthetic injection safe for humans?

Local anaesthetic injections are generally safe for humans, with adverse events being rare. However, some localized complications can occur, but they are usually manageable. ^{1 2 3 4 5}

How does the local anaesthetic injection treatment for postoperative pain in inguinal hernia differ from other treatments?

Local anaesthetic injection for postoperative pain in inguinal hernia is unique because it provides targeted pain relief directly at the surgical site, potentially reducing the need for systemic pain medications. This method can offer a pain-free period of approximately 10 hours, allowing for early mobilization and shorter hospital stays compared to other treatments like spinal anaesthesia. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Local Anaesthetic Injection for postoperative pain in inguinal hernia?

Research shows that using local anaesthetic injections for inguinal hernia repair can reduce the need for pain medication, shorten hospital stays, and lower complication rates, making it an effective option for managing postoperative pain. ^{1 2 3 8 9}

Who Is on the Research Team?

Erol Onel

Principal Investigator

Cali Biosciences

Are You a Good Fit for This Trial?

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.

Able to sign Informed Consent

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive local infiltration of CPL-01, placebo, or Ropivacaine HCl after herniorrhaphy

Immediate post-surgery

Follow-up

Participants are monitored for pain control and safety after treatment

72 hours

Extended Follow-up

Participants may be monitored for any long-term effects or complications

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Local Anaesthetic Injection

Trial Overview 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.

How Is the Trial Designed?

Group I: CPL-01 Experimental Treatment 1 Intervention

Local infiltration of CPL-01

Group II: Ropivacaine HCl Active Control 1 Intervention

Local infiltration of Naropin

Group III: Placebo Placebo Group 1 Intervention

Local infiltration of Saline Placebo

Who Is Running the Clinical Trial?

Cali Pharmaceuticals LLC

Lead Sponsor

Trials

5

Recruited

1,300+

Published Research Related to This Trial

Local anesthetics are generally safe and adverse events are rare, allowing for their frequent use in medical and dental procedures.

Despite their safety, complications can still occur with local anesthetic administration, and while practitioners can take steps to prevent them, not all complications can be avoided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localized complications from local anesthesia. Haas, DA.[2005]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Pain after groin hernia repair. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A randomised study of ilio-inguinal nerve blocks following inguinal hernia repair: a stopped randomised controlled trial. [2018]

3. France pubmed.ncbi.nlm.nih.gov

Pain during and after-hernioplasty in raquidian or locorregional anesthesia by locking peripheral nerves. [2021]

4. Pakistan pubmed.ncbi.nlm.nih.gov

Efficacy Of Local Anaesthesia In Repair Of Inguinal Hernia. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

[Inguinal hernia repair with local anesthesia--a comparative analysis]. [2019]

6. Italy pubmed.ncbi.nlm.nih.gov

Tension-free hernioplasty of recurrent inguinal hernia under local anaesthesia: a 5-year review. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Localized complications from local anesthesia. [2005]

8. Pakistan pubmed.ncbi.nlm.nih.gov

COMPARISON OF EFFICACY OF SPINAL ANAESTHESIA AND SUB- FASCIAL LOCAL ANAESTHETIC INGUINAL FIELD BLOCK FOR OPEN INGUINAL HERNIA REPAIR-A SINGLE INSTITUTIONAL EXPERIENCE. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of dextran with local anaesthesia for short-stay inguinal herniorraphy. [2018]