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 evaluates the effectiveness of a local anesthetic injection in reducing pain after inguinal hernia surgery. Participants will receive one of three treatments: a new drug called CPL-01 (an experimental treatment), an existing anesthetic called Ropivacaine HCl, or a placebo (a harmless, inactive substance). The goal is to determine which option best alleviates postoperative pain. Individuals scheduled for inguinal hernia repair and in generally good health may qualify for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially new pain relief option.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found CPL-01 to be safe and well-tolerated, with no major safety concerns reported. This treatment is a long-lasting version of ropivacaine, a local pain reliever often used to manage pain. Research shows that it offers extended pain relief without serious side effects.

Ropivacaine HCl, also known by its brand name Naropin, has been safely used for pain management in various medical procedures. Studies have shown that it is less likely to cause temporary muscle weakness compared to other pain relievers, which is a positive safety feature.

Overall, both CPL-01 and ropivacaine HCl have demonstrated good safety records in previous research, supporting their use for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for postoperative pain in inguinal hernia, which often involve systemic medications like opioids or NSAIDs, CPL-01 offers a localized approach. CPL-01 is a local anaesthetic injection that directly targets the surgical site, potentially reducing the need for systemic pain relief and its associated side effects. Researchers are excited about CPL-01 because it may provide effective pain control right where it's needed, with fewer side effects and a lower risk of addiction compared to traditional systemic pain medications. This targeted action could lead to quicker recovery times and improved patient comfort after surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain in inguinal hernia?

Research shows that local anesthetic injections can effectively reduce pain after inguinal hernia surgery. In this trial, participants may receive CPL-01, a new long-lasting form of the pain reliever ropivacaine, which has shown promise in managing pain and reducing the need for opioids after surgery. One study found that patients using CPL-01 felt less pain compared to those who received a placebo. Another arm of this trial involves the use of ropivacaine itself, which has proven effective in preventing pain after hernia repair, with studies reporting significant reductions in pain levels. Overall, both CPL-01 and ropivacaine have strong potential to aid recovery by reducing pain after surgery. ^{1 2 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11297089/

CPL-01, an investigational long-acting ropivacaine ... Results suggest that CPL-01 may be the first long-acting ropivacaine to address postoperative pain while reducing the need for opioids.

2. withpower.com withpower.com/trial/phase-3-pain-postoperative-3-2023-b96da

Local Anaesthetic Injection for Postoperative Pain in ... Research shows that using local anaesthetic injections for inguinal hernia repair can reduce the need for pain medication, shorten hospital stays, and lower ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966653298000298

Postoperative pain relief and recovery with ropivacaine ... The results of this study confirm the efficacy of ropivacaine infiltration in preventing postoperative pain after inguinal hernia repair. At a dosage of 300 ...

4. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-abdominal-wall-surgery/articles/10.3389/jaws.2025.14317/full

A Novel One-Stop Multidisciplinary Clinic for Chronic ... Pain scores (VAS) decreased from 7.2 to 2.8, and functional activity (mAAS) improved from 20.3 to 9.7 (p < 0.0001). Patient satisfaction was ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/53/NCT02055053/Prot_SAP_000.pdf

Effects of Local Anesthesia on Post-operative Pain During ... Controlling post-operative pain is a standard part of managing any post-operative patient. Laparoscopic Total.

6. researchgate.net researchgate.net/publication/396097946_A_Phase_I_Study_to_Evaluate_the_Safety_Tolerability_Pharmacokinetics_and_Efficacy_of_QP002_for_the_Treatment_of_Post-Operative_Pain_After_Tension-Free_Repair_of_Open_Unilateral_Inguinal_Hernia

(PDF) A Phase I Study to Evaluate the Safety, Tolerability, ... Results A total of 40 patients with unilateral inguinal hernia were included in this study. In comparison to 0.25% bupivacaine hydrochloride 75 ...

7. dovepress.com dovepress.com/a-phase-i-study-to-evaluate-the-safety-tolerability-pharmacokinetics-a-peer-reviewed-fulltext-article-DDDT

A Phase I Study to Evaluate the Safety, Tolerability, and ... Results: A total of 40 patients with unilateral inguinal hernia were included in this study. In comparison to 0.25% bupivacaine hydrochloride 75 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1015958421006400

Novel local anesthesia technique 'NATURE ' (Nerves And ... The use of local anaesthesia infiltration techniques may attenuate pain following endo-laparoscopic inguinal hernia surgery. We aim to reduce post-operative ...