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

Not Applicable

• Conditions: Clavicle Fracture
• Interventions: Procedure: ISB; Procedure: SCPB; Procedure: SCPB + ISB; Drug: Bupivacaine hydrogen chloride , epinephrine

• Registration Number: NCT03094481
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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.

Detailed Description

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10-21
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-03-29
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03
• Primary Completion: 2019-11-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• undergoing open reduction and internal fixation of clavicle fracture (midshaft or lateral)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US guided ISB medial fracture	ISB	Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
US guided ISB lateral fracture	ISB	Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
US guided SCPB + ISB lateral fracture	Bupivacaine hydrogen chloride , epinephrine	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.
US guided SCPB lateral fracture	SCPB	Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
US guided SCPB + ISB lateral fracture	SCPB + ISB	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.
US guided SCPB medial fracture	Bupivacaine hydrogen chloride , epinephrine	Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
US guided ISB medial fracture	Bupivacaine hydrogen chloride , epinephrine	Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
US guided SCPB + ISB medial fracture	Bupivacaine hydrogen chloride , epinephrine	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.
US guided SCPB medial fracture	SCPB	Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
US guided SCPB + ISB medial fracture	SCPB + ISB	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.
US guided SCPB lateral fracture	Bupivacaine hydrogen chloride , epinephrine	Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
US guided ISB lateral fracture	Bupivacaine hydrogen chloride , epinephrine	Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.

Primary Outcome Measures

Name	Time	Method
Pain measurement using NRS in PACU	1 hour post-op	Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada