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Local Anesthetic
US guided ISB lateral fracture for Collarbone Fracture
N/A
Waitlist Available
Led By Paul McHardy, MD, FRCPC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* undergoing open reduction and internal fixation of clavicle fracture (midshaft or lateral)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours post-op
Awards & highlights
Approved for 20 Other Conditions
No Placebo-Only Group
Summary
The optimal analgesic peripheral nerve block (or combinations thereof) are undefined for clavicle fractures, the most frequent fracture in the human population. This goal of this study is to determine whether interscalene block (ISB), superficial cervical plexus block (SCPB), or both provide the best analgesia for lateral and midshaft clavicular fractures, respectively.
Eligible Conditions
- Collarbone Fracture
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 hours post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours post-op
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain measurement using NRS in PACU
Secondary study objectives
Opioid consumption in morphine equivalence
Pain measurement using NRS at Discharge
Satisfaction using rating scale
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Active Control
Group I: US guided ISB lateral fractureActive Control2 Interventions
Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
Group II: US guided SCPB medial fractureActive Control2 Interventions
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
Group III: US guided ISB medial fractureActive Control2 Interventions
Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
Group IV: US guided SCPB + ISB medial fractureActive Control2 Interventions
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
Group V: US guided SCPB + ISB lateral fractureActive Control2 Interventions
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
Group VI: US guided SCPB lateral fractureActive Control2 Interventions
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,735 Total Patients Enrolled
Paul McHardy, MD, FRCPCPrincipal InvestigatorSunnybrook Health Sciences Centre
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