A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

Durect

Status and phase

Completed

Phase 2

Conditions

Postoperative Pain

Treatments

Drug: SABER-Bupivacaine

Drug: SABER-Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00818363

C803-017

Details and patient eligibility

About

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 (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 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 criteria

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.