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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once
Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
Unnamed facility
Cairns, Queensland, Australia
Unnamed facility
Sunnybank, Queensland, Australia
Unnamed facility
Port Lincoln, South Australia, Australia
Unnamed facility
Ringwood East, Victoria, Australia
Unnamed facility
Hamilton, New Zealand
Pain Intensity on Movement
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.
Time frame: 1 to 72 hours post-dose
Proportion (Percent) of Patients Using Supplemental Opioids
Time frame: 0 to 14 days post-dose
Pain Intensity
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.
Time frame: 1 to 48 hours post-dose
Treatment Satisfaction
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).
Time frame: 1 to 5 days post-dose
Supplemental Opioid Use
Time frame: 0 to 14 days post-dose
Mean Function Activities (Modified Brief Pain Inventory)
In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)
Time frame: 1 to 5 days post-dose
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