Postsurgical Analgesia After Hernia Repair

Launched by AMACATHERA INC. · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called AMT-143 to help manage pain after surgery for a type of hernia repair known as inguinal hernia. The researchers want to find out if different doses of AMT-143 are safe and effective for reducing pain following surgery. To do this, they will enroll 30 healthy adults, both men and women, who are at least 18 years old and scheduled for this surgery. Participants will receive either the AMT-143 medication, a saline placebo (which has no active ingredients), or a standard pain relief solution called ropivacaine. The study will be conducted at one clinical site, and participants will not know which treatment they receive.

To be eligible for the trial, participants must be generally healthy and have a body mass index (BMI) of 40 or less. Women must not be pregnant or breastfeeding and must agree to use reliable birth control during the study. Participants will be monitored closely in the hospital for a few hours after surgery and will have follow-up visits at home for up to 21 days after the treatment. A final visit will take place 28 days after the surgery. This study aims to find the best dose of AMT-143 to help manage pain effectively while ensuring safety for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provides voluntary written informed consent.
• • 2. Participants are ≥18 years of age at screening.
• • 3. Scheduled to undergo unilateral open inguinal hernia repair.
• • 4. Body mass index (BMI) ≤40.0 kg/m2.
• • 5. 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.
• 6. 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.
• • 7. 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:
• • 1. 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.
• • 2. History of hypersensitivity to any ingredient in the formulation (hyaluronan or methylcellulose).
• • 3. History of hypersensitivity or allergy to amide type local anaesthetics (lidocaine, bupivacaine, or ropivacaine).
• • 4. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker.
• • 5. Have a clinically significant abnormal clinical laboratory test value, according to the judgement of the investigator.
• • 6. Have a clinically significant 12-lead ECG abnormality, according to the judgement of the investigator.
• • 7. 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).
• • 8. Have received any investigational product within 30 days before dosing with study medication.
• • 9. Suspected or known history of substance abuse and/or alcoholism.