Interscalene vs. Superficial Cervical Block vs. Combination for Analgesia After Clavicle Fracture

Study Overview
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Brief Summary
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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.

Detailed Description
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Clavicle fractures are relatively common injuries that occur most often in young active males and elderly individuals. They are often a result of direct trauma to the shoulder, typically from a fall. Clavicle fractures represent 5-10% of all fractures and represent the most frequent fracture in the human population. Midshaft fractures account for 69-85% of the clavicle fractures, distal shaft fractures 12-28%. (1) Analgesia for clavicle fractures can be challenging for anaesthetists secondary to the complex and varied innervation in this region. Literature describing the innervation of the clavicle and overlying skin is heterogeneous with the C3 to C6 nerve roots being involved. The clavicle itself has been reported to be innervated either by C4 or by C5 and C6 (subclavian nerve) nerve roots. (2) Regional anaesthesia for intraoperative and postoperative analgesia of clavicle fractures employs several possible, commonly used approaches. The contemporary literature surrounding the optimal regional anaesthetic technique for clavicle surgery which can provide superior postoperative analgesia and minimize systemic agents intraoperatively is lacking Currently there are only small case series or case reports published. Peripheral nerve blocks used to anesthetize the clavicle include SCPB, ISB, and combined SCPB-ISB. Larger, systematic trials have not yet been performed to our knowledge and as recently as one year ago a call for more evidence in this area of regional anaesthesia was published in the American Society of Regional Anesthesia and Pain Medicine. The purpose of this study is to compare analgesic outcomes after the common regional anesthetic techniques (ISB versus SCPB versus both).

Official Title
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Comparison of Interscalene vs. Superficial Cervical Block vs. Combination of Both Blocks for Analgesia After Operative Repair of Midshaft and Lateral Clavicle Fractures

Conditions
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Clavicle Fracture

Intervention / Treatment
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* Procedure: SCPB
* Procedure: ISB
* Procedure: SCPB + ISB
* Drug: Bupivacaine hydrogen chloride , epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing open reduction and internal fixation of clavicle fracture (midshaft or lateral) Exclusion Criteria: lack of patient consent contra-indication to upper extremity peripheral nerve block (eg. severe pulmonary dysfunction) inability to lie supine for nerve block polytrauma pre-existing neurologic deficit in operative upper extremity allergy to amide local anesthetic contralateral phrenic nerve dysfunction chronic opioid use (>30mg daily oral morphine equivalent)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: US guided SCPB medial fracture<br>Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. | Procedure: SCPB<br>* Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.<br>* Other names: Superficial Cervical Plexus;Drug: Bupivacaine hydrogen chloride , epinephrine<br>* Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine<br>|
| Active Comparator: US guided ISB medial fracture<br>Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6. | Procedure: ISB<br>* Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.<br>* Other names: Interscalene Brachial Plexus;Drug: Bupivacaine hydrogen chloride , epinephrine<br>* Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine<br>|
| Active Comparator: US guided SCPB + ISB medial fracture<br>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. | Procedure: SCPB + ISB<br>* Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided SCPB at C4 or C5 + 10ml injected for ISB at C5 or C6.<br>* Other names: Superficial Cervical Plexus & Interscalene Brachial Plexus;Drug: Bupivacaine hydrogen chloride , epinephrine<br>* Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine<br>|
| Active Comparator: US guided SCPB lateral fracture<br>Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. | Procedure: SCPB<br>* Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.<br>* Other names: Superficial Cervical Plexus;Drug: Bupivacaine hydrogen chloride , epinephrine<br>* Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine<br>|
| Active Comparator: US guided ISB lateral fracture<br>Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6. | Procedure: ISB<br>* Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.<br>* Other names: Interscalene Brachial Plexus;Drug: Bupivacaine hydrogen chloride , epinephrine<br>* Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine<br>|
| Active Comparator: US guided SCPB + ISB lateral fracture<br>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. | Procedure: SCPB + ISB<br>* Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided SCPB at C4 or C5 + 10ml injected for ISB at C5 or C6.<br>* Other names: Superficial Cervical Plexus & Interscalene Brachial Plexus;Drug: Bupivacaine hydrogen chloride , epinephrine<br>* Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement using NRS in PACU | Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit | 1 hour post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement using NRS at Discharge | Numeric Rating Scale for Pain upon discharge from hospital | 4 hours post-op | 
| Opioid consumption in morphine equivalence | Total postoperative opioid consumption from end of operation to hospital discharge | 4 hours post-op | 
| Satisfaction using rating scale | Patient satisfaction with postoperative analgesia at time of discharge | 4 hours post-op |