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

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

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.

Study Overview

• Status: Unknown
• Conditions: Clavicle Fracture
• Intervention / Treatment: Procedure: SCPB; Drug: Bupivacaine hydrogen chloride , epinephrine; Procedure: ISB; Procedure: SCPB + ISB

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).

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Paul McHardy, MD; Phone Number: pg x 6626 416-480-6100; Email: paul.mchardy@sunnybrook.ca
      • Principal Investigator: Paul McHardy, MD
      • Sub-Investigator: Stephen Choi, MD
      • Sub-Investigator: Patrick Henry, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: SCPB; Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.; Other Names: Superficial Cervical Plexus; Drug: Bupivacaine hydrogen chloride , epinephrine; Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine
Active Comparator: 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.	Drug: Bupivacaine hydrogen chloride , epinephrine; Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine; Procedure: ISB; Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.; Other Names: Interscalene Brachial Plexus
Active Comparator: 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.	Drug: Bupivacaine hydrogen chloride , epinephrine; Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine; 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.; Other Names: Superficial Cervical Plexus & Interscalene Brachial Plexus
Active Comparator: 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.	Procedure: SCPB; Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.; Other Names: Superficial Cervical Plexus; Drug: Bupivacaine hydrogen chloride , epinephrine; Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine
Active Comparator: 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.	Drug: Bupivacaine hydrogen chloride , epinephrine; Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine; Procedure: ISB; Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.; Other Names: Interscalene Brachial Plexus
Active Comparator: 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.	Drug: Bupivacaine hydrogen chloride , epinephrine; Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine; 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.; Other Names: Superficial Cervical Plexus & Interscalene Brachial Plexus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Paul McHardy, MD, FRCPC, Sunnybrook Health Sciences Centre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2016
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: 036-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No