Postsurgical Analgesia After Hernia Repair | NCT06709612

NCT06709612

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Intervention Names
AMT-143	Experimental	Drug: AMT-143
Saline Placebo	Placebo Comparator	Other: Saline (NaCl 0,9 %) (placebo)
Ropivacaine solution	Active Comparator	Drug: ropivacaine

Name	Type	Description	Arm Group Labels	Other Names
AMT-143	Drug	AMT-143 is provided as a hydrogel containing 385 mg/mL ropivacaine (on a ropivacaine hydrochloride equivalence basis). Participants undergoing primary open hernia repair, will be randomized to one of three treatment cohorts of escalating doses of AMT-143 hydrogel: Cohort 1: 1 mL AMT-143 hydrogel Cohort 2: 2 mL AMT-143 hydrogel Cohort 3: 3 mL AMT-143 hydrogel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events to evaluate the safety and tolerability of AMT-143	To evaluate the safety and tolerability of AMT-143 for postsurgical pain management following inguinal hernia repair surgery. The safety endpoint of the study will be the incidence of Treatment Emergent Adverse Events (TEAEs). This will include reported Adverse Events as well as all clinically significant abnormalities in clinical laboratory investigations, vital signs, physical examination results, and ECG tracings.	From surgery to Day 28 follow-up
Pharmacokinetics of AMT-143	To assess the PK profile of AMT-143. Plasma samples will be analyzed for ropivacaine concentrations using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Incurred sample reanalysis will be performed on approximately 10% of study samples with a minimum of 20 samples for confirmation of results. At least two thirds of the incurred samples analyzed should have a percent difference between re-assay & original concentrations within ±20%. Plasma concentration-time data for AMT-143 will be analyzed by the noncompartmental method to obtain the PK parameters using validated Phoenix WinNonlin® version 8.3 or higher software (Pharsight Corp).	From surgery to Day 28 follow-up

Secondary Outcomes

Measure	Description	Time Frame
Analgesic efficacy of AMT-143	To evaluate analgesic efficacy of AMT-143 for postsurgical pain management following inguinal hernia repair surgery utilizing the Numeric Rating Scale (NRS). The NRS runs from 0 (no pain) to 10 (worst pain).	From surgery to Day 28 follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The following inclusion criteria apply to all participants scheduled for open inguinal hernia repair in all cohorts.

Provides voluntary written informed consent.
Participants are ≥18 years of age at screening.
Scheduled to undergo unilateral open inguinal hernia repair.
Body mass index (BMI) ≤40.0 kg/m2.
Male participants must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication.
Female participants:
- Not pregnant (female participant of childbearing potential must have a negative urine pregnancy test before surgery).
- Not lactating.
- Not planning to become pregnant during the study.
- Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by Health Canada for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study.
In the opinion of the Investigator, is willing and able to understand the study procedures, and agrees to adhere to the requirements of the study protocol, in order to enable accurate and appropriate responses to pain scales.

Exclusion Criteria:

The following exclusion criteria apply to all participants in all cohorts.

Have chronic pain and have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation.
History of hypersensitivity to any ingredient in the formulation (hyaluronan or methylcellulose).
History of hypersensitivity or allergy to amide type local anaesthetics (lidocaine, bupivacaine, or ropivacaine).
History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker.
Have a clinically significant abnormal clinical laboratory test value, according to the judgement of the investigator.
Have a clinically significant 12-lead ECG abnormality, according to the judgement of the investigator.
Have received any medications with a potential for drug interactions with ropivacaine (i.e., amide-type local anaesthetics such as lidocaine, bupivacaine, mepivacaine and prilocaine; antiarrhythmics such as procainamide, disopyramide, tocainide, mexiletine and flecainide; sedative; strong inhibitors of cytochrome P4501A2 such as fluvoxamine enoxacin, theophylline and imipramine for at least 5 half-lives prior to the start of this).
Have received any investigational product within 30 days before dosing with study medication.
Suspected or known history of substance abuse and/or alcoholism.

ID	Term
D006552	Hernia, Inguinal
D006547	Hernia

ID	Term
D046449	Hernia, Abdominal
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012965	Sodium Chloride
D000077212	Ropivacaine