Herniorrhaphy for Postoperative Pain

NCT05813847 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: CPL-01-301
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain; Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

• Pain control

  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

Study Arms (3)

CPL-01

EXPERIMENTAL

Local infiltration of CPL-01

Drug: local anaesthetic injection of CPL-01; Drug: Morphine (rescue medication); Drug: Acetaminophen (rescue medication); Drug: Oxycodone (rescue medication); Procedure: Open inguinal hernia repair

Ropivacaine HCl

ACTIVE COMPARATOR

Local infiltration of Naropin

Drug: Morphine (rescue medication); Drug: Acetaminophen (rescue medication); Drug: Oxycodone (rescue medication); Drug: local anaesthetic injection of ropivacaine HCl; Procedure: Open inguinal hernia repair

Placebo

PLACEBO COMPARATOR

Local infiltration of Saline Placebo

Drug: Morphine (rescue medication); Drug: Acetaminophen (rescue medication); Drug: Oxycodone (rescue medication); Drug: local anaesthetic injection of placebo; Procedure: Open inguinal hernia repair

Interventions

local anaesthetic injection of CPL-01 DRUG

Local infiltration of study drug

Also known as: CPL-01

CPL-01

Morphine (rescue medication) DRUG

Opioid rescue allowed by IV if requested

Also known as: Opioid (Intravenous [IV] morphine) rescue medication

CPL-01; Placebo; Ropivacaine HCl

Acetaminophen (rescue medication) DRUG

Acetaminophen rescue allowed if requested

Also known as: Non-opioid (oral [PO] acetaminophen) rescue medication

CPL-01; Placebo; Ropivacaine HCl

Oxycodone (rescue medication) DRUG

Opioid rescue allowed by mouth if requested

Also known as: Opioid (oral [PO] oxycodone) rescue medication

CPL-01; Placebo; Ropivacaine HCl

local anaesthetic injection of placebo DRUG

Local infiltration of study drug

Also known as: Normal Saline

Placebo

local anaesthetic injection of ropivacaine HCl DRUG

Local infiltration of study drug

Also known as: Naropin

Ropivacaine HCl

Open inguinal hernia repair PROCEDURE

Surgical hernia repair

Also known as: Herniorrhaphy

CPL-01; Placebo; Ropivacaine HCl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cali Pharmaceuticals LLC: lead

Study Sites (1)

Todd Bertoch

Salt Lake City, Utah, 84101, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

Morphine; Analgesics, Opioid; Acetaminophen; Oxycodone; Saline Solution; Ropivacaine; Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Erol Onel

  Cali Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: April 18, 2023
• Primary Completion: September 15, 2025
• Study Completion: October 6, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)