Clinical trial NCT00818363: A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery
Official title: A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: Postoperative pain
shoulder surgery
opioid
Lead sponsor: Durect
Sponsor class: INDUSTRY
Collaborators: name: Nycomed
First posted: 2009-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.


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 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.

Primary outcomes:
measure: Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.
timeFrame: 0 to 72 hours post-dose
measure: Supplemental Opioid Use
timeFrame: 0 to 72 hours post-dose
Secondary outcomes:
measure: Number (Frequency) of Participants Reporting Opioid-related Adverse Events
timeFrame: 0 to 72 hours post-dose
measure: Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose).
timeFrame: 0 to 48 hours post-dose
measure: Supplemental Opioid Use
timeFrame: 0 to 48 hours post-dose
measure: Time-to-first Use of Opioid Supplemental Pain Medication
timeFrame: 0 to 14 days post-dose
measure: Severity of Opioid-related Side Effects
timeFrame: 0 to 14 days post-dose
Other outcomes:
Locations:
city: Westmead
country: Australia
state: New South Wales
city: Kippa Ring
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Toorak Gardens
country: Australia
state: South Australia
city: Geelong
country: Australia
state: Victoria
city: Hampton
country: Australia
state: Victoria
city: Ringwood East
country: Australia
state: Victoria
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
Study officials:
affiliation: Durect
name: Dmitri Lissin, MD
role: STUDY_DIRECTOR
References:
citation: Hadj A, Hadj A, Hadj A, Rosenfeldt F, Nicholson D, Moodie J, Turner R, Watts R, Fletcher I, Abrouk N, Lissin D. Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial. ANZ J Surg. 2012 Apr;82(4):251-7. doi: 10.1111/j.1445-2197.2011.05754.x. Epub 2011 Jun 24.