Hernia, Inguinal, Post Operative Pain
Conditions
Brief summary
Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.
Detailed description
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.
Interventions
DRUGlocal anaesthetic injection of CPL-01
Local infiltration of study drug
DRUGMorphine (rescue medication)
Opioid rescue allowed by IV if requested
DRUGAcetaminophen (rescue medication)
Acetaminophen rescue allowed if requested
DRUGOxycodone (rescue medication)
Opioid rescue allowed by mouth if requested
DRUGlocal anaesthetic injection of placebo
Local infiltration of study drug
DRUGlocal anaesthetic injection of ropivacaine HCl
Local infiltration of study drug
PROCEDUREOpen inguinal hernia repair
Surgical hernia repair
Sponsors
Cali Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORErol Onel
Cali Biosciences
Outcome results
None listed