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. The purpose of this study is to investigate safety (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
331
Injectable Extended Release Solution; SABER-Bupivacaine /Once
Injectable Solution; Bupivacaine HCl /Once
Injectable Solution; SABER-Placebo/Once
DURECT Study Site
Birmingham, Alabama, United States
Mean Pain Intensity on Movement
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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: 0 to 72 hours post-dose
Supplemental Opioid Use
Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
Time frame: 0-72 hours post dose
Mean Pain Intensity on Movement
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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: 0 to 48 hours post-dose
Total Morphine-equivalent Dose
Total morphine-equivalent dose during 0-48 hours post dose.
Time frame: 0-48 hours post dose
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
From Surgical Wound Healing and Local Tissue Condition Evaluation
Time frame: 0 to 14 days post-dose (Visits 3 and 4)
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DURECT Study Site
Florence, Alabama, United States
DURECT Study Site
Mobile, Alabama, United States
DURECT Study Site
Mobile, Alabama, United States
DURECT Study Site
Montgomery, Alabama, United States
DURECT Study Site
Sheffield, Alabama, United States
DURECT Study Site
Arcadia, California, United States
DURECT Study Site
Fontana, California, United States
DURECT Study Site
Laguna Hills, California, United States
DURECT Study Site
Pasadena, California, United States
...and 16 more locations
Time-to-first Use of Opioid Rescue Medication
Time frame: 0 to 14 days post-dose (Time from extubation until first opioid use)
Number (Incidence) of Participants With Opioid-related Side Effects
AEs include: nausea, vomiting, constipation, dizziness, somnolence, urinary retention, respiratory depression
Time frame: 0 to 30 days post-dose
Pain Intensity at Rest AUC During 0-72 Hours Post Dose
Mean pain intensity at rest AUC during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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: 0-72 hours post dose
Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose
Mean pain intensity at rest AUC during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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: 0-48 hours post dose