Local Anaesthetic Injection for Postoperative Pain in Inguinal Hernia
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive local infiltration of CPL-01, placebo, or Ropivacaine HCl after herniorrhaphy
Follow-up
Participants are monitored for pain control and safety after treatment
Extended Follow-up
Participants may be monitored for any long-term effects or complications
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?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Local infiltration of CPL-01
Local infiltration of Naropin
Local infiltration of Saline Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cali Pharmaceuticals LLC
Lead Sponsor
Published Research Related to This Trial
Citations
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.
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 ...
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/fullA 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 ...
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.
(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-DDDTA 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 ...
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 ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.