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A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery

Post Operative Pain Clinical Trial

Official title:
A Single-dose, Open-Label, Multi-center Study to Assess the Safety and Preliminary Efficacy of PRF 110 (Formerly LNP) in Open Herniorrhaphy Surgery

Clinical Trial Summary

LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the Pharmacokinetic (PK) profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.

Clinical Trial Description

LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The formulation is designed to slowly release the ropivacaine over 36-72 hours. By providing local analgesia over a long time span, the need for systemic analgesics is expected to be reduced and hospital stays may be shortened. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the PK profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01681966
Study type Interventional
Source PainReform LTD
Contact
Status Completed
Phase Phase 2
Start date September 2012
Completion date May 4, 2016
View Details
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