Status:
COMPLETED
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
Lead Sponsor:
Durect
Collaborating Sponsors:
Nycomed
Conditions:
Postoperative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, effica...
Eligibility Criteria
Inclusion
- Subacromial impingement syndrome
- MRI with intact rotator cuff
- Patients suitable for general anaesthesia
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00993798
Start Date
April 1 2009
End Date
November 1 2011
Last Update
June 9 2021
Active Locations (10)
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1
Nycomed Investigational Site
Graz, Austria
2
Nycomed Investigational Site
Vienna, Austria, 1090
3
Nycomed Investigational Site
Vienna, Austria, 1130
4
Nycomed Investigational Site
Berlin, Germany