Status:
COMPLETED
A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery
Lead Sponsor:
Durect
Collaborating Sponsors:
Nycomed
Conditions:
Postoperative Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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 to 65 years of age, scheduled for shoulder surgery.
- Patients must be healthy or have only mild systemic disease.
- Patients must have ECG wave form within normal limits
- Patients must have blood pressure within normal range.
- Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed.
- Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial.
Exclusion
- Patients with previous arthroscopic surgery or open surgery on the study shoulder.
- Patients with chronic pain conditions requiring continuous use of corticosteroids for greater than 3 months.
- Patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory arthropathies.
- Patients with a below normal calculated creatinine clearance.
- Patients who are pregnant or lactating.
- Patients currently receiving more than 20 mg of hydrocodone daily (or equivalent narcotic dose) on routine basis.
- Patients, who in the Investigator's opinion, have developed opioid tolerance.
- Patients with current or regular use of anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors at screening.
- Patients with current or regular use of drugs known to significantly prolong the corrected QT interval
- Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g., lidocaine, bupivacaine).
- Patients with known hypersensitivity to opioids.
- Patients with conditions contraindicated for use of opioids.
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00818363
Start Date
December 1 2008
End Date
October 1 2009
Last Update
June 1 2021
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Westmead, New South Wales, Australia, 2145
2
Kippa-Ring, Queensland, Australia, 4021
3
Adelaide, South Australia, Australia, 5000
4
Toorak Gardens, South Australia, Australia, 5065