Inguinal hernia repair Classification code 10022020
Conditions
Interventions
Product Name: Saber™ Bupivacaine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Bupivacaine
CAS Number: 2180-92-9
Other descriptive name: 1-Butyl -N-(2,6-dimethylphenyl)-2-piperidine
Sponsors
DURECT Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Males and females, 18 to 70 years of age who are planned to undergo ambulatory open repair of inguinal hernia under local anaesthesia, and requiring an incision of 4-6 cm in length; - Determined to be in good health prior to study participation based on a medical history, physical examination, ECG and laboratory tests; - Body Mass Index (BMI) no more than 35 kg/m2; - Systolic blood pressure no greater than 160 mm Hg and diastolic blood pressure no greater than 95 mmHg; - A requirement that males and females must agree to use a medically acceptable method of contraception throughout the study period and for 1 week after the study is completed. Acceptable methods that may be used are abstinence, birth control pills or patch, diaphragm with spermicide, IUD (coil), condom and foam, surgical sterilization and progestin implant or injection; - A requirement to refrain from strenuous activities and avoid modifications to current exercise levels throughout the course of the study; - Ability to read, understand, communicate, and voluntarily sign the approved Informed Consent Form prior to the performance of any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy or lactating; - Presence of abdominal surgery with scar tissue that would limit patients ability to participate; - Evidence of clinically significant hepatic, gastrointestinal, renal, hematologic, urologic, neurologic, respiratory, endocrine or cardiovascular system abnormalities, psychiatric disorders, or acute infection; - Connective tissue disorders (systemic lupus erythematosus, scleroderma, mixed connective tissue disease); - Current or regular use at Screening of triptyline or imipramine antidepressants, monoamine oxidase inhibitors; - Known or suspected alcohol abuse within the 6 months prior to study enrollment or illicit drug use; - Use of any prescription drugs or over the counter medication starting within 7 days before treatment and throughout the study (except for birth control medications) that may interfere with the conduct or interpretation of the study results; - Participation in another clinical study concurrent or within 30 days of enrollment; - Known sensitivity to bupivacaine or other study drugs or their constituents; - Patient is unwilling or unable to comply with the study visit schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective is to determine how safe and tolerable SABER™ Bupivacaine is as well as measuring the blood levels(pharmacokinetics) and pharmacodynamics (effectiveness) of SABER™ Bupivacaine and/or bupivacaine hydrochloride when these are given to patients undergoing an open inguinal hernia repair operation.;Secondary Objective: ;Primary end point(s): Analysis of the Sum of Pain Intensity Difference (SPID) and Total Pain Relief (Days 1-5) | — |
Countries
United Kingdom
Outcome results
None listed