Skip to main content
OpenTrials
Completed

NCT Number: NCT05813847

Herniorrhaphy for Postoperative Pain

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Todd Bertoch

Salt Lake City, Utah, 84101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

local anaesthetic injection of CPL-01

Drug

Local infiltration of study drug

Other names: CPL-01

Morphine (rescue medication)

Drug

Opioid rescue allowed by IV if requested

Other names: Opioid (Intravenous [IV] morphine) rescue medication

Acetaminophen (rescue medication)

Drug

Acetaminophen rescue allowed if requested

Other names: Non-opioid (oral [PO] acetaminophen) rescue medication

Oxycodone (rescue medication)

Drug

Opioid rescue allowed by mouth if requested

Other names: Opioid (oral [PO] oxycodone) rescue medication

local anaesthetic injection of placebo

Drug

Local infiltration of study drug

Other names: Normal Saline

local anaesthetic injection of ropivacaine HCl

Drug

Local infiltration of study drug

Other names: Naropin

Open Inguinal Hernia Repair

Procedure

Surgical hernia repair

Other names: Herniorrhaphy

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cali Pharmaceuticals LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.