Bupivacaine Effectiveness and Safety in SABER Trial (BESST)
Overview
- Phase
- Phase 3
- Intervention
- SABER-Bupivacaine
- Conditions
- Postoperative Pain
- Sponsor
- Durect
- Enrollment
- 331
- Locations
- 1
- Primary Endpoint
- Supplemental Opioid Use
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff
- •Males and females, 18 years of age and older scheduled to undergo elective general abdominal surgery
- •Patients must be healthy or have only mild systemic disease
- •BMI \< 45
- •Patients must have ECG wave form within normal limits
- •Female and male patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial participation is completed
Exclusion Criteria
- •Patients who are pregnant or lactating
- •Patients undergoing emergency surgery (unless full consent is obtained and all screening procedures are completed prior to surgery)
- •Significant concomitant surgical procedure
- •History of multiple prior laparotomy procedures
- •Cancer with known metastases pre-operatively, which are suspected to impact post-operative recovery or pain
- •Planned formation of stoma during surgery or plans to undergo another laparotomy procedure within 30 days post-operatively
- •Pre-operative evidence of sepsis or septic shock
- •Pre-operative evaluation that suggests a surgery may preclude full closure of the incision(s)
- •Patients with current or regular use of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications
- •Patients with current or regular use of drugs known to significantly prolong the QTc interval
Arms & Interventions
Active: SABER-Bupivacaine
SABER-Bupivacaine
Intervention: SABER-Bupivacaine
Comparator: Bupivacaine HCl
Bupivacaine HCl
Intervention: Bupivacaine HCl
Placebo: SABER-Placebo
SABER-Placebo
Intervention: SABER-Placebo
Outcomes
Primary Outcomes
Supplemental Opioid Use
Time Frame: 0-72 hours post dose
Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
Mean Pain Intensity on Movement
Time Frame: 0 to 72 hours post-dose
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.
Secondary Outcomes
- Total Morphine-equivalent Dose(0-48 hours post dose)
- Proportion (Percent) of Patients Who Have Evidence of a Wound Infection(0 to 14 days post-dose (Visits 3 and 4))
- Time-to-first Use of Opioid Rescue Medication(0 to 14 days post-dose (Time from extubation until first opioid use))
- Pain Intensity at Rest AUC During 0-72 Hours Post Dose(0-72 hours post dose)
- Mean Pain Intensity on Movement(0 to 48 hours post-dose)
- Number (Incidence) of Participants With Opioid-related Side Effects(0 to 30 days post-dose)
- Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose(0-48 hours post dose)