Herniorrhaphy for Postoperative Pain

April 23, 2026 updated by: Cali Pharmaceuticals LLC

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy

Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects pain and rescue medication use is assessed after having received either CPL-01, placebo, or ropivacaine HCl for several days after hernia repair surgery.

Study Type

Interventional

Enrollment (Actual)

518

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84101
        • Todd Bertoch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPL-01
Local infiltration of CPL-01
Drug: local anaesthetic injection of CPL-01
Local infiltration of study drug
Other Names:
  • CPL-01
Drug: Morphine (rescue medication)
Opioid rescue allowed by IV if requested
Other Names:
  • Opioid (Intravenous [IV] morphine) rescue medication
Drug: Acetaminophen (rescue medication)
Acetaminophen rescue allowed if requested
Other Names:
  • Non-opioid (oral [PO] acetaminophen) rescue medication
Drug: Oxycodone (rescue medication)
Opioid rescue allowed by mouth if requested
Other Names:
  • Opioid (oral [PO] oxycodone) rescue medication
Procedure: Open inguinal hernia repair
Surgical hernia repair
Other Names:
  • Herniorrhaphy
Active Comparator: Ropivacaine HCl
Local infiltration of Naropin
Drug: Morphine (rescue medication)
Opioid rescue allowed by IV if requested
Other Names:
  • Opioid (Intravenous [IV] morphine) rescue medication
Drug: Acetaminophen (rescue medication)
Acetaminophen rescue allowed if requested
Other Names:
  • Non-opioid (oral [PO] acetaminophen) rescue medication
Drug: Oxycodone (rescue medication)
Opioid rescue allowed by mouth if requested
Other Names:
  • Opioid (oral [PO] oxycodone) rescue medication
Procedure: Open inguinal hernia repair
Surgical hernia repair
Other Names:
  • Herniorrhaphy
Drug: local anaesthetic injection of ropivacaine HCl
Local infiltration of study drug
Other Names:
  • Naropin
Placebo Comparator: Placebo
Local infiltration of Saline Placebo
Drug: Morphine (rescue medication)
Opioid rescue allowed by IV if requested
Other Names:
  • Opioid (Intravenous [IV] morphine) rescue medication
Drug: Acetaminophen (rescue medication)
Acetaminophen rescue allowed if requested
Other Names:
  • Non-opioid (oral [PO] acetaminophen) rescue medication
Drug: Oxycodone (rescue medication)
Opioid rescue allowed by mouth if requested
Other Names:
  • Opioid (oral [PO] oxycodone) rescue medication
Procedure: Open inguinal hernia repair
Surgical hernia repair
Other Names:
  • Herniorrhaphy
Drug: local anaesthetic injection of placebo
Local infiltration of study drug
Other Names:
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain control
Time Frame: 72 hours
Area under the curve of the numeric rating score for pain with activity, where 0 is no pain and 10 is worst pain imaginable
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cali Pharmaceuticals LLC

Investigators

  • Study Director: Erol Onel, Cali Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2023

Primary Completion (Actual)

September 15, 2025

Study Completion (Actual)

October 6, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPL-01-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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