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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study Summary

This trial studies how well an experimental treatment works in people who have had hernia surgery.

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.Check my eligibility
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.See study design
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.
Select...
I am not pregnant nor planning to become pregnant.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain control

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

Find a Location

Who is running the clinical trial?

Cali Pharmaceuticals LLCLead Sponsor
4 Previous Clinical Trials
772 Total Patients Enrolled
Erol OnelStudy DirectorCali Biosciences
2 Previous Clinical Trials
647 Total Patients Enrolled

Media Library

Local Anaesthetic Injection (Local Anaesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05813847 — Phase 3
Inguinal Hernia Research Study Groups: CPL-01, Placebo, Ropivacaine HCl
Inguinal Hernia Clinical Trial 2023: Local Anaesthetic Injection Highlights & Side Effects. Trial Name: NCT05813847 — Phase 3
Local Anaesthetic Injection (Local Anaesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05813847 — Phase 3
Inguinal Hernia Patient Testimony for trial: Trial Name: NCT05813847 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study open to participants of 45 years and older?

"This clinical trial has outlined inclusion criteria wherein only individuals aged 18 to 75 are eligible for enrolment."

Answered by AI

Has the FDA given clearance to CPL-01 for public consumption?

"Our assessment of CPL-01's safety yields a score of 3, signifying the presence of prior clinical evidence attesting to its efficacy and multiple rounds that affirm its security."

Answered by AI

Is enrollment in this research study taking place presently?

"Data gathered from clinicaltrials.gov verifies that this study is actively recruiting participants, with the initial posting dating back to April 7th 2023 and last edited on 4/3/2023."

Answered by AI

How many participants have been recruited for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this investigation is currently in need of participants and was initially posted on the 7th of April 2023 with a recent update on the 3rd of April 2023. 504 individuals are being enrolled at one location for this venture."

Answered by AI

What criteria must be met to qualify for entry into this investigation?

"Eligibility for this clinical trial requires patients possessing an inguinal hernia and aged between 18 to 75 years old. Approximately 504 individuals are needed."

Answered by AI

Who else is applying?

What site did they apply to?
Todd Bertoch
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What state do they live in?
Utah

Why did patients apply to this trial?

need surgery and can't afford it on my own.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Todd Bertoch: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Herniorrhaphy for Postoperative Pain
2023. "Herniorrhaphy for Postoperative Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05813847.
~0 spots leftby Apr 2024
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