An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery

An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery

The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.

Inclusion Criteria:

• Subacromial impingement syndrome
• MRI with intact rotator cuff
• Patients suitable for general anaesthesia

Exclusion Criteria:

• Known major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen shoulder or previous surgery of the affected shoulder
• Abnormal ECG
• Prolonged QT syndrome
• Current or regular use of analgesic medication for other indication(s)