An International Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
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ClinicalTrials.gov Identifier: NCT00993798 |
Recruitment Status :
Completed
First Posted : October 12, 2009
Last Update Posted : February 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Pain | Drug: SABER-Bupivacaine Treatment 1a Drug: Placebo SABER-Bupivacaine Treatment 1b Drug: Bupivacaine HCl Treatment 1c Drug: SABER-Bupivacaine Treatment 2a Drug: Placebo SABER-Bupivacaine Treatment 2b Drug: Bupivacaine HCl Treatment 2c | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: SABER-Bupivacaine Treatment 1a
double-blind
|
Drug: SABER-Bupivacaine Treatment 1a
5.0 ml |
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 1b
double-blind
|
Drug: Placebo SABER-Bupivacaine Treatment 1b
5.0 ml |
Active Comparator: Bupivacaine HCl Treatment 1c
double-blind
|
Drug: Bupivacaine HCl Treatment 1c
20.0 ml |
Experimental: SABER-Bupivacaine Treatment 2a
double-blind
|
Drug: SABER-Bupivacaine Treatment 2a
7.5 ml |
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 2b
double-blind
|
Drug: Placebo SABER-Bupivacaine Treatment 2b
7.5 ml |
Active Comparator: Bupivacaine HCl Treatment 2c
double-blind
|
Drug: Bupivacaine HCl Treatment 2c
20.0 ml |
- Pain intensity (PI) [ Time Frame: 0-3 days after surgery ]
- Supplemental opioid use [ Time Frame: 0-3 days after surgery ]
- Time to first opioid rescue medication usage [ Time Frame: 0-14 days after surgery ]
- Frequency of opioid related side effects [ Time Frame: 0-7 days after surgery ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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 ClinicalTrials.gov identifier (NCT number): NCT00993798
Austria | |
Nycomed Investigational Site | |
Graz, Austria | |
Nycomed Investigational Site | |
Vienna, Austria, 1090 | |
Nycomed Investigational Site | |
Vienna, Austria, 1130 | |
Denmark | |
Nycomed Investigational Site | |
Skoerping, Denmark | |
Germany | |
Nycomed Investigational Site | |
Berlin, Germany | |
Nycomed Investigational Site | |
Dresden, Germany | |
Nycomed Investigational Site | |
Marburg, Germany | |
Latvia | |
Nycomed Investigational Site | |
Riga, Latvia | |
Nycomed Investigational Site | |
Valmiera, Latvia | |
Poland | |
Nycomed Investigational Site | |
Lodz, Poland | |
Sweden | |
Nycomed Investigational Site | |
Stockholm, Sweden |
Study Chair: | Nycomed Clinical Trial Operations | Headquarters |
Responsible Party: | Durect |
ClinicalTrials.gov Identifier: | NCT00993798 |
Other Study ID Numbers: |
BU-002-IM |
First Posted: | October 12, 2009 Key Record Dates |
Last Update Posted: | February 4, 2013 |
Last Verified: | January 2013 |
Post operative pain Local anaesthesia Postoperative pain after arthroscopic shoulder surgery |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Bupivacaine |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |