Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Durect
With
Nycomed
Hospira, now a wholly owned subsidiary of Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications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
Clareo Health | Bupivacaine Effectiveness and Safety in SABER® Trial
