Herniorrhaphy for Postoperative Pain

Hernia, Inguinal Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813847
• Other study ID #: CPL-01-301
• Status: Recruiting
• Phase: Phase 3
• Start date: April 18, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Cali Pharmaceuticals LLC
• Contact: Erol Onel
• Phone: 2038376500
• Email: e.onel[@]calibiosciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: July 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia, Inguinal
• Pain, Postoperative

Intervention

Drug:
• local anaesthetic injection
Local infiltration of study drug

Locations

Country	Name	City	State
United States	Todd Bertoch	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Cali Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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