A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

Phase 2

Completed

Brief Summary: This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia.

The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.

Recruitment & Eligibility

Inclusion Criteria

Males and females, 18 to 65 years of age, scheduled for hernia repair surgery
Patients must be in good health prior to study participation
Patients must have blood pressure within normal range or with Stage 1 high blood pressure
Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed
Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial
Ability to read, understand, communicate, and voluntarily sign the informed consent form prior to any trial specific procedures

Exclusion Criteria

Patients with previous abdominal surgery scar tissue
Patients with clinically significant abnormalities of any body system unrelated to the disease under study
Connective tissue disorders
Patients who are pregnant or lactating
Current or regular use of analgesic medication for other indications
Patients with current or regular use of antidepressants or monoamine oxidase inhibitors at screening
Use of any drugs or medication that may interfere with the study and its results
Patients with known hypersensitivity to the study drugs or their components
Patients with known or suspected alcohol abuse or illicit drug use
Participation in another clinical trial at the same time or within 30 days of this trial
Patient is unwilling to comply with the study procedures

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Proportion (Percent) of Patients Using Supplemental Opioids	0 to 14 days post-dose
Pain Intensity on Movement	1 to 72 hours post-dose	Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

Secondary Outcome Measures

Name	Time	Method
Supplemental Opioid Use	0 to 14 days post-dose
Pain Intensity	1 to 48 hours post-dose	Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Treatment Satisfaction	1 to 5 days post-dose	Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied).
Mean Function Activities (Modified Brief Pain Inventory)	1 to 5 days post-dose	In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)