Phase 3
Completed N=331
Bupivacaine Effectiveness and Safety in SABER® Trial
Postoperative Pain · Abdominal Surgery
Source: ClinicalTrials.gov NCT01052012 ↗
Enrolled (actual)
331
Serious AEs
12.8%
Results posted
Jun 2021
Primary outcomePrimary: Mean Pain Intensity on Movement — 4.9; 5.0; 2.8; 3.9 score on a scale — p=0.1473
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pain Intensity on Movement |
5.2; 6.0; 3.2; 4.4; 5.2; 5.5 | — |
| PRIMARY Supplemental Opioid Use |
87.0; 63.0; 17.0; 22.5; 52.0; 62.0 | 0.9901 |
| SECONDARY Mean Pain Intensity on Movement |
5.2; 6.0; 3.2; 4.4; 5.2; 5.5 | — |
| SECONDARY Total Morphine-equivalent Dose |
69.5; 52.0; 15.0; 19.7; 41.5; 43.0 | — |
| SECONDARY Proportion (Percent) of Patients Who Have Evidence of a Wound Infection |
2; 1; 0; 0; 6; 0 | — |
| SECONDARY Time-to-first Use of Opioid Rescue Medication |
0.6; 0.5; 0.6; 0.5; 0.6; 0.5 | — |
| SECONDARY Number (Incidence) of Participants With Opioid-related Side Effects |
19; 10; 23; 17; 93; 47 | — |
| SECONDARY Pain Intensity at Rest AUC During 0-72 Hours Post Dose |
3.4; 4.2; 1.7; 2.5; 3.1; 3.5 | — |
| SECONDARY Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose |
3.6; 4.5; 2.0; 2.9; 3.4; 3.8 | — |
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
- Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g. lidocaine, bupivacaine)
- Patients with known hypersensitivity to morphine
- Patients with conditions contraindicated for use of opioids
- Patients with atrial fibrillation/flutter or other non-sinus rhythm (including paced rhythm); left bundle branch block (LBBB); or the following conditions: right bundle branch block (RBBB) in presence of a cardiac disease, significant cardiomyopathy, and myocardial infarction within last 6 months
- Patients with a serum creatinine level two times more than the local laboratory normal limit
- Patients who have received greater than 600 mg morphine equivalent daily dose for three or more days per week in the month prior to the surgical procedure
- Patients who are currently being treated with methadone, or history of methadone use within the previous 6 months
- Patients with known or suspected abuse of opioids or other illicit drugs
- Patients with known or suspected alcohol abuse
- Participation in another clinical trial at the same time or within 30 days of this trial
- Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
Data sourced from ClinicalTrials.gov (NCT01052012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.