Herniorrhaphy for Postoperative Pain

Phase 3

Recruiting

• Conditions: Hernia, Inguinal
• Interventions: Drug: local anaesthetic injection

• Registration Number: NCT05813847
• Lead Sponsor: Cali Pharmaceuticals LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-14
• Study Start: 2023-04-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 504

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine HCl	local anaesthetic injection	Local infiltration of Naropin
Placebo	local anaesthetic injection	Local infiltration of Saline Placebo
CPL-01	local anaesthetic injection	Local infiltration of CPL-01

Primary Outcome Measures

Name	Time	Method
Pain control	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

Trial Locations

Locations (1)

Todd Bertoch; 🇺🇸 Salt Lake City, Utah, United States