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Ropivacaine

Phase 3

Local Anesthetic | Small molecule | Other |Community Health Systems, Inc.|Last Updated: Jun 14, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

Ropivacaine · 1 trial · 1 indication

Phase 3 1
NCT00825786Ultrasound Guided Supraclavicular Nerve BlockLocal Anesthetic
COMPLETED103 Analytics
PHASE3COMPLETED
Ultrasound Guided Supraclavicular Nerve Block
Local AnestheticUnlock trial analytics

Study Endpoints

Primary Endpoints

Duration of Analgesia.
During surgery: postoperative day 0

The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.

Secondary Endpoints

Time to Complete Motor Block
during surgery from induction time to end case time
Time to Onset of First Sensory Block
during surgery
Maximum Verbal Response Score (VRS) With Rest
through post operative day 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1ACTIVE_COMPARATORcombined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Group 2ACTIVE_COMPARATORsequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.

Interventions

NameTypeDescription
RopivacaineDRUGropivacaine (15 ml).
MepivacaineDRUGOne syringe will contain mepivacaine (15 ml)
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients undergoing upper extremity procedures suitable for supraclavicular anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery * Age between 18 and 70 years Exclusion Criteria: * Contraindications to supraclavicular block * Coagulopathy...

Countries:United States
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