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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00818363
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : August 22, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: SABER™-Bupivacaine Drug: SABER™-Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 1: SABER™-Bupivacaine
5.0 mL SABER™-Bupivacaine/Once
Drug: SABER™-Bupivacaine
Injectable Extended Release Solution; 5.0 mL SABER™-Bupivacaine/Once

Placebo Comparator: Group 2: SABER™-Placebo
5.0 mL SABER™-Placebo/Once
Drug: SABER™-Placebo
Injectable Solution; 5.0 mL SABER™-Placebo/Once

Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 0 to 3 days post-dose ]
  2. Supplemental opioid use [ Time Frame: 0 to 3 days post-dose ]

Secondary Outcome Measures :
  1. Frequency of opioid related side effects [ Time Frame: 0 to 14 days post-dose ]
  2. Pain Intensity [ Time Frame: 0 to 2 days post-dose ]
  3. Supplemental opioid use [ Time Frame: 0 to 2 days post-dose ]
  4. Time-to-first use of opioid supplemental pain medication [ Time Frame: 0 to 14 days post-dose ]
  5. Severity of opioid-related side effects [ Time Frame: 0 to 14 days post-dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00818363

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Australia, New South Wales
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Kippa Ring, Queensland, Australia, 4021
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Toorak Gardens, South Australia, Australia, 5065
Australia, Victoria
Geelong, Victoria, Australia, 3220
Hampton, Victoria, Australia, 3188
Ringwood East, Victoria, Australia, 3135
New Zealand
Christchurch, New Zealand
Hamilton, New Zealand
Sponsors and Collaborators
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Study Director: Dmitri Lissin, MD Durect
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Durect Identifier: NCT00818363    
Other Study ID Numbers: C803-017
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by Durect:
Postoperative pain
shoulder surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents