CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
SABER-Bupivacaine +1 moredrug
Likely dose
SABER-Bupivacaine 5.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00818363
NCT00818363Phase 2Completed
CompareCT.gov

A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery

Durect·interventional·Posted Jan 7, 2009·Updated Jun 1, 2021

In Brief

A Phase 2 clinical trial evaluating SABER-Bupivacaine and SABER-Placebo for Postoperative Pain. Completed, enrolled 60 participants across 9 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesAustralia, New Zealand
CollaboratorsNycomed

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2009
Enrollment StartDec 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.5 years ago

Interventions

SABER-Bupivacainedrug

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

SABER-Placebodrug

Injectable Solution; 5.0 mL SABER-Placebo/Once