Hernia, InguinalPhase 3NCT05813847
Herniorrhaphy for Postoperative Pain
A Phase 3 study testing local anaesthetic injection of CPL-01, Morphine (rescue medication) and Acetaminophen (rescue medication) in people with Hernia, Inguinal and Post Operative Pain, run by Cali Pharmaceuticals LLC at 1 site in United States.
Trial summary
Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hernia, Inguinal, Post Operative Pain
- What is being tested?
- local anaesthetic injection of CPL-01, Morphine (rescue medication) and Acetaminophen (rescue medication)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2023to 6 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.
Read the 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.
- Conditions
- Hernia, Inguinal, Post Operative Pain
- Being tested
- local anaesthetic injection of CPL-01, Morphine (rescue medication), Acetaminophen (rescue medication), Oxycodone (rescue medication), local anaesthetic injection of placebo
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anaesthetic injection of CPL-01Drug
Also called CPL-01
Local infiltration of study drug
Morphine (rescue medication)Drug
Also called Opioid (Intravenous [IV] morphine) rescue medication
Opioid rescue allowed by IV if requested
Acetaminophen (rescue medication)Drug
Also called Non-opioid (oral [PO] acetaminophen) rescue medication
Acetaminophen rescue allowed if requested
Oxycodone (rescue medication)Drug
Also called Opioid (oral [PO] oxycodone) rescue medication
Opioid rescue allowed by mouth if requested
local anaesthetic injection of placeboDrug
Also called Normal Saline
Local infiltration of study drug
local anaesthetic injection of ropivacaine HClDrug
Also called Naropin
Local infiltration of study drug
Open inguinal hernia repairProcedure or surgery
Also called Herniorrhaphy
Surgical hernia repair
| Study group | Role | What they receive |
|---|---|---|
| CPL-01 | Experimental | Local infiltration of CPL-01 Receives: Drug: local anaesthetic injection of CPL-01; Drug: Morphine (rescue medication); Drug: Acetaminophen (rescue medication); Drug: Oxycodone (rescue medication); Procedure: Open inguinal hernia repair |
| Ropivacaine HCl | Active comparator | Local infiltration of Naropin Receives: Drug: Morphine (rescue medication); Drug: Acetaminophen (rescue medication); Drug: Oxycodone (rescue medication); Drug: local anaesthetic injection of ropivacaine HCl; Procedure: Open inguinal hernia repair |
| Placebo | Placebo comparator | Local infiltration of Saline Placebo Receives: Drug: Morphine (rescue medication); Drug: Acetaminophen (rescue medication); Drug: Oxycodone (rescue medication); Drug: local anaesthetic injection of placebo; Procedure: Open inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start18 Apr 2023
- Primary completion15 Sep 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cali Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erol Onel, Study director, Cali Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813847
- Sponsor's protocol ID
- CPL-01-301
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05813847
- Acronym / sponsor ID
- CPL-01-301
- Conditions
- Hernia, Inguinal, Post Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Cali Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPL-01 | Experimental | Drug: local anaesthetic injection of CPL-01, Drug: Morphine (rescue medication), Drug: Acetaminophen (rescue medication), Drug: Oxycodone (rescue medication), Procedure: Open inguinal hernia repairLocal infiltration of CPL-01 |
| Ropivacaine HCl | Active comparator | Drug: Morphine (rescue medication), Drug: Acetaminophen (rescue medication), Drug: Oxycodone (rescue medication), Drug: local anaesthetic injection of ropivacaine HCl, Procedure: Open inguinal hernia repairLocal infiltration of Naropin |
| Placebo | Placebo comparator | Drug: Morphine (rescue medication), Drug: Acetaminophen (rescue medication), Drug: Oxycodone (rescue medication), Drug: local anaesthetic injection of placebo, Procedure: Open inguinal hernia repairLocal infiltration of Saline Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anaesthetic injection of CPL-01Also: CPL-01Local infiltration of study drug | Drug | CPL-01 |
| Morphine (rescue medication)Also: Opioid (Intravenous [IV] morphine) rescue medicationOpioid rescue allowed by IV if requested | Drug | CPL-01, Placebo, Ropivacaine HCl |
| Acetaminophen (rescue medication)Also: Non-opioid (oral [PO] acetaminophen) rescue medicationAcetaminophen rescue allowed if requested | Drug | CPL-01, Placebo, Ropivacaine HCl |
| Oxycodone (rescue medication)Also: Opioid (oral [PO] oxycodone) rescue medicationOpioid rescue allowed by mouth if requested | Drug | CPL-01, Placebo, Ropivacaine HCl |
| local anaesthetic injection of placeboAlso: Normal SalineLocal infiltration of study drug | Drug | Placebo |
| local anaesthetic injection of ropivacaine HClAlso: NaropinLocal infiltration of study drug | Drug | Ropivacaine HCl |
| Open inguinal hernia repairAlso: HerniorrhaphySurgical hernia repair | Procedure or surgery | CPL-01, Placebo, Ropivacaine HCl |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erol Onel study director
Cali Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing local anaesthetic injection of CPL-01, Morphine (rescue medication) and Acetaminophen (rescue medication) in people with Hernia, Inguinal and Post Operative Pain, run by Cali Pharmaceuticals LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain control (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.