NCT01557270

Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder Surgery

The Efficacy and Safety of Dexmedetomidine as an Additive to Ropivacaine for Interscalene Brachial Plexus Blocks for Shoulder Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Prof. Peter Gerner, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the efficacy and safety of dexmedetomidine added to ropivacaine in patients undergoing shoulder surgery.

Detailed description

Peripheral nerve blocks are used throughout the world in lieu of general anesthesia and, more commonly, to provide analgesia and opioid sparing in the postoperative course. Long acting local anesthetics, such as ropivacaine, can provide analgesia for 11.5 ± 5 hours. This leads to many patients reporting their first pain in the evening and nighttime hours when access to healthcare providers and support is most limited. A number of additives to local anesthetics have been studied in humans with limited success. Recent work by a group in Michigan found a dose dependent increase in the duration of analgesia to a thermal stimulus when dexmedetomidine was added to ropivacaine for sciatic nerve blocks in rat. The goal of the study is to investigate the safety and efficacy of dexmedetomidine added to ropivacaine for interscalene brachial plexus nerve block for shoulder surgery in humans. Provided the initial safety can be established, the trial will continue to evaluate secondary goals including the duration of analgesia, onset of sensory and motor blockade, and opioid-induced side effects. Tertiary outcomes will include subject satisfaction.

Conditions

• Drug Safety
• Self Efficacy

Interventions

Type	Name	Description
DRUG	dexmedetomidine	ropivacaine 100 mg + 150 mcg dexmedetomidine, single shot perineural application
DRUG	saline	ropivacaine + saline placebo, single shot perineural application

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-03-19
• Last updated: 2012-12-04

Locations

1 site across 1 country: Austria