Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
14 participants
INTERVENTIONAL
2018-05-29
2020-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ropivacaine
Single injection of ropivacaine immediately prior to surgery
Ropivacaine
Single injection of ropivacaine immediately prior to surgery.
Ropivacaine plus Nerve Block
Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.
Ropivacaine
Single injection of ropivacaine immediately prior to surgery.
Nerve block
insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Interventions
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Ropivacaine
Single injection of ropivacaine immediately prior to surgery.
Nerve block
insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unable to complete surveys in English
* Unable to understand instructions for using pump in English
* Unavailable for followup
* Polytrauma; undergoing other surgeries or having other orthopedic injuries related to the precipitating cause of the ankle fracture
* Infection
* Peripheral vascular disease
* Diabetes
* Currently undergoing chemotherapy
* Pregnancy
* Currently lactating
* Heart disease or heart rhythm disorder or taking anti-arrhythmic drugs
* Severe renal impairment (Class 3 or worse kidney disease)
* Liver disease (cirrhosis or liver failure)
* Prior allergic reaction to any type of local anesthetic
* Taking therapeutic doses of anti-coagulants or anti-platelet therapy (prophylactic doses started because of hospital admission are not an exclusion)
* Currently taking antidepressants or other psychiatric medications
* Single shot local nerve block prior to surgery was ineffective
* Selected for neuraxial anesthesia rather than general anesthesia for the open reduction surgery
* Already receiving chronic analgesic therapy for a separate chronic pain condition
18 Years
65 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Jun-ming Zhang
Professor of Anesthesia
Principal Investigators
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Jun-Ming Zhang, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati Medical Center
Cincinnati, Ohio, United States
UC Health West Chester Hosptial
West Chester, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Zhang2016
Identifier Type: -
Identifier Source: org_study_id
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