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

NCT ID: NCT03094481

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-21

Study Completion Date

2020-03-01

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.

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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).

Conditions

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Clavicle Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
All parties will be blinded except for the specific anesthesiologist performing the nerve blocks. This person will not be involved in providing further care (administering anesthesia) nor data collection.

Study Groups

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US guided SCPB + ISB lateral fracture

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 Type ACTIVE_COMPARATOR

SCPB + ISB

Intervention Type PROCEDURE

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.

Bupivacaine hydrogen chloride , epinephrine

Intervention Type DRUG

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine

US guided SCPB medial fracture

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.

Group Type ACTIVE_COMPARATOR

SCPB

Intervention Type PROCEDURE

Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.

Bupivacaine hydrogen chloride , epinephrine

Intervention Type DRUG

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine

US guided ISB medial fracture

Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.

Group Type ACTIVE_COMPARATOR

ISB

Intervention Type PROCEDURE

Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.

Bupivacaine hydrogen chloride , epinephrine

Intervention Type DRUG

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine

US guided SCPB + ISB medial fracture

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 Type ACTIVE_COMPARATOR

SCPB + ISB

Intervention Type PROCEDURE

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.

Bupivacaine hydrogen chloride , epinephrine

Intervention Type DRUG

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine

US guided SCPB lateral fracture

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.

Group Type ACTIVE_COMPARATOR

SCPB

Intervention Type PROCEDURE

Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.

Bupivacaine hydrogen chloride , epinephrine

Intervention Type DRUG

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine

US guided ISB lateral fracture

Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.

Group Type ACTIVE_COMPARATOR

ISB

Intervention Type PROCEDURE

Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.

Bupivacaine hydrogen chloride , epinephrine

Intervention Type DRUG

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine

Interventions

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SCPB

Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.

Intervention Type PROCEDURE

ISB

Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.

Intervention Type PROCEDURE

SCPB + ISB

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.

Intervention Type PROCEDURE

Bupivacaine hydrogen chloride , epinephrine

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine

Intervention Type DRUG

Other Intervention Names

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Superficial Cervical Plexus Interscalene Brachial Plexus Superficial Cervical Plexus & Interscalene Brachial Plexus

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Paul McHardy

Assistant Professor, Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul McHardy, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Paul McHardy, MD, FRCPC

Role: CONTACT

[email protected]
4164804864

Shelly Au, PhD, PMP

Role: CONTACT

[email protected]
4164806100 ext. 89607

Facility Contacts

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Paul McHardy, MD

Role: primary

[email protected]
416-480-6100 ext. pg x 6626

References

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Faldini C, Nanni M, Leonetti D, Acri F, Galante C, Luciani D, Giannini S. Nonoperative treatment of closed displaced midshaft clavicle fractures. J Orthop Traumatol. 2010 Dec;11(4):229-36. doi: 10.1007/s10195-010-0113-z. Epub 2010 Oct 9.

Reference Type BACKGROUND
PMID: 20936323 (View on PubMed)

Choi DS, Atchabahian A, Brown AR. Cervical plexus block provides postoperative analgesia after clavicle surgery. Anesth Analg. 2005 May;100(5):1542-1543. doi: 10.1213/01.ANE.0000149049.08815.00. No abstract available.

Reference Type BACKGROUND
PMID: 15845732 (View on PubMed)

Tran DQ, Tiyaprasertkul W, Gonzalez AP. Analgesia for clavicular fracture and surgery: a call for evidence. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):539-43. doi: 10.1097/AAP.0000000000000012.

Reference Type BACKGROUND
PMID: 24121609 (View on PubMed)

Other Identifiers

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036-2016

Identifier Type: -

Identifier Source: org_study_id

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