Herniorrhaphy for Postoperative Pain

Description

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

Conditions

Hernia, Inguinal

Study Overview

Study Details

Study overview

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

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

Herniorrhaphy for Postoperative Pain

Condition
Hernia, Inguinal
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cali Pharmaceuticals LLC,

Erol Onel, STUDY_DIRECTOR, Cali Biosciences

Study Record Dates

2024-12-31