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SABER-Bupivacaine for Postoperative Pain in Shoulder Surgery
NCT00993798Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2009
- Primary completion
- Jun 2011
- Countries
- 5
- Sponsor
- DURECT Corporation
- Modality
- Hydrogel Systems, Small Molecules
- Drugs
- Posimir
- Conditions
- postoperative pain
01
Overview
Phase 2, randomised, double-blind trial of Posimir in postoperative pain (6 arms), sponsored by DURECT Corporation. Primary endpoints: Pain Intensity (PI) and Supplemental Opioid Use. Started Apr 2009; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Posimir 5.0 ml
SABER-Bupivacaine 5.0 ml
Placebo 5.0 ml
Placebo SABER-Bupivacaine 5.0 ml
Bupivacaine HCl 20.0 ml (Cohort 1)
Bupivacaine HCl 20.0 ml
Posimir 7.5 ml
SABER-Bupivacaine 7.5 ml
Placebo 7.5 ml
Placebo SABER-Bupivacaine 7.5 ml
Bupivacaine HCl 20.0 ml (Cohort 2)
Bupivacaine HCl 20.0 ml
03
Who it enrols
Patients with subacromial impingement syndrome undergoing elective arthroscopic shoulder surgery, suitable for general anaesthesia, with intact rotator cuff on MRI.
04
Endpoints
Primary
Pain Intensity (PI)
Supplemental Opioid Use
Secondary
Time to First Opioid Rescue Medication Usage
Opioid Related Side Effects
05
Results
Primary endpoints met
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