Self Efficacy Clinical Trial
Official title:
The Efficacy and Safety of Dexmedetomidine as an Additive to Ropivacaine for Interscalene Brachial Plexus Blocks for Shoulder Surgery
The purpose of this study is to test the efficacy and safety of dexmedetomidine added to ropivacaine in patients undergoing shoulder surgery.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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