Bupivacaine Effectiveness and Safety in SABER® Trial

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 (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.

Timeline

Start

2009-12

Primary completion

2011-09

Completion

2011-09

Outcome

Missed primary endpoint

registry Cohort 1-POSIMIR vs Cohort 1-Bupivacaine HCl; p = 0.1473; LS Mean Difference (Final Values) -0.89 (95% CI -2.11 to 0.33); ANCOVA NCT01052012 ↗

registry Cohort 2-POSIMIR vs Cohort 2-Bupivacaine HCl; p = 0.0601; LS Mean Difference (Final Values) -1.06 (95% CI -2.16 to 0.05); ANCOVA NCT01052012 ↗

registry Cohort 3-POSIMIR vs Cohort 3-Placebo; p = 0.1483; LS Mean Difference (Final Values) -0.34 (95% CI -0.80 to 0.12); ANCOVA NCT01052012 ↗

registry Cohort 1-POSIMIR vs Cohort 1-Bupivacaine HCl; p = 0.9901; Median Difference (Hodge-Lehmann) -1.0 (95% CI -54.5 to 52.0); Wilcoxon (Mann-Whitney) NCT01052012 ↗

registry Cohort 2-POSIMIR vs Cohort 2-Bupivacaine HCl; p = 0.2010; Median Difference (Hodge-Lehmann) -5.0 (95% CI -14.0 to 3.4); Wilcoxon Rank-Sum NCT01052012 ↗

registry Cohort 3-POSIMIR vs Cohort 3-Placebo; p = 0.5897; Median Difference (Hodge-Lehmann) -3.0 (95% CI -15.0 to 8.0); Wilcoxon Rank-Sum NCT01052012 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	—	—

Indications

No indication recorded.