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New painkiller injection could ease recovery after hernia repair

NCT ID NCT05813847

Symptom relief Sponsor: Cali Pharmaceuticals LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new local anesthetic called CPL-01 to control pain after open inguinal hernia repair. 518 adults received either CPL-01, a placebo, or an active control injection right after surgery. Researchers measured pain levels during activity over time to see if CPL-01 provides better relief than standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CPL-01 (a local anesthetic injection)
What this could lead to
If it works, this could provide a new way to manage pain after hernia surgery, potentially reducing the need for opioids.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. The treatment may not prove better than existing options, and any new drug carries risks of side effects like allergic reactions or injection-site issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

518 people

The number who actually took part.

Started

Apr 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to sign Informed Consent * Scheduled to have inguinal hernia repair * Be a reasonably healthy adult 18 - 75 years of age * Body mass index ≤ 39 kg/m2 * If biologically female, not pregnant or planning to become pregnant * If biologically male, using acceptable birth control * Be willing and able to complete study procedures Exclusion Criteria: * Previously inguinal herniorrhaphy * Concurrent painful condition that may require analgesic treatment * History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation * Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months * History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. * Impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis. * Impaired renal function (e.g., creatinine \> 1.5 × ULN). * Malignancy in the past year * Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.

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Conditions

The condition(s) this trial relates to.

Hernia, Inguinal Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hernia, inguinal Post operative pain

Contacts and locations

Locations

  • Todd Bertoch

    Salt Lake City, Utah, 84101, United States

More trials for these conditions

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