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

NCT ID: NCT00818363

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-10-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: SABER-Bupivacaine

5.0 mL SABER-Bupivacaine/Once

Group Type: EXPERIMENTAL

SABER-Bupivacaine

Intervention Type: DRUG

Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once

Group 2: SABER-Placebo

5.0 mL SABER-Placebo/Once

Group Type: PLACEBO_COMPARATOR

SABER-Placebo

Intervention Type: DRUG

Injectable Solution; 5.0 mL SABER-Placebo/Once

Interventions

SABER-Bupivacaine

Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once

Intervention Type: DRUG

SABER-Placebo

Injectable Solution; 5.0 mL SABER-Placebo/Once

Intervention Type: DRUG

Other Intervention Names

POSIMIR® bupivacaine solution

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nycomed

INDUSTRY

Sponsor Role: collaborator

Durect

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dmitri Lissin, MD

Role: STUDY_DIRECTOR

Durect

Locations

Westmead, New South Wales, Australia

Kippa-Ring, Queensland, Australia

Adelaide, South Australia, Australia

Toorak Gardens, South Australia, Australia

Geelong, Victoria, Australia

Hampton, Victoria, Australia

Ringwood East, Victoria, Australia

Christchurch, , New Zealand

Hamilton, , New Zealand

Countries

Australia; New Zealand

References

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.

Reference Type: DERIVED

PMID: 22510183 (View on PubMed)

Other Identifiers

C803-017

Identifier Type: -

Identifier Source: org_study_id