search
Back to results

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

Primary Purpose

Clavicle Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SCPB
ISB
SCPB + ISB
Bupivacaine hydrogen chloride , epinephrine
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clavicle Fracture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

US guided SCPB medial fracture

US guided ISB medial fracture

US guided SCPB + ISB medial fracture

US guided SCPB lateral fracture

US guided ISB lateral fracture

US guided SCPB + ISB lateral fracture

Arm Description

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

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

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.

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

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

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.

Outcomes

Primary Outcome Measures

Pain measurement using NRS in PACU
Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2017
Last Updated
May 2, 2018
Sponsor
Sunnybrook Health Sciences Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT03094481
Brief Title
Interscalene vs. Superficial Cervical Block vs. Combination for Analgesia After Clavicle Fracture
Official Title
Comparison of Interscalene vs. Superficial Cervical Block vs. Combination of Both Blocks for Analgesia After Operative Repair of Midshaft and Lateral Clavicle Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 21, 2016 (Actual)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
US guided SCPB medial fracture
Arm Type
Active Comparator
Arm Description
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
Arm Title
US guided ISB medial fracture
Arm Type
Active Comparator
Arm Description
Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
Arm Title
US guided SCPB + ISB medial fracture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
US guided SCPB lateral fracture
Arm Type
Active Comparator
Arm Description
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
Arm Title
US guided ISB lateral fracture
Arm Type
Active Comparator
Arm Description
Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
Arm Title
US guided SCPB + ISB lateral fracture
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
SCPB
Other Intervention Name(s)
Superficial Cervical Plexus
Intervention Description
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.
Intervention Type
Procedure
Intervention Name(s)
ISB
Other Intervention Name(s)
Interscalene Brachial Plexus
Intervention Description
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.
Intervention Type
Procedure
Intervention Name(s)
SCPB + ISB
Other Intervention Name(s)
Superficial Cervical Plexus & Interscalene Brachial Plexus
Intervention Description
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
Drug
Intervention Name(s)
Bupivacaine hydrogen chloride , epinephrine
Intervention Description
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine
Primary Outcome Measure Information:
Title
Pain measurement using NRS in PACU
Description
Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit
Time Frame
1 hour post-op
Secondary Outcome Measure Information:
Title
Pain measurement using NRS at Discharge
Description
Numeric Rating Scale for Pain upon discharge from hospital
Time Frame
4 hours post-op
Title
Opioid consumption in morphine equivalence
Description
Total postoperative opioid consumption from end of operation to hospital discharge
Time Frame
4 hours post-op
Title
Satisfaction using rating scale
Description
Patient satisfaction with postoperative analgesia at time of discharge
Time Frame
4 hours post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul McHardy, MD, FRCPC
Phone
4164804864
Email
paul.mchardy@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Shelly Au, PhD, PMP
Phone
4164806100
Ext
89607
Email
shelly.au@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul McHardy, MD, FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul McHardy, MD
Phone
416-480-6100
Ext
pg x 6626
Email
paul.mchardy@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Paul McHardy, MD
First Name & Middle Initial & Last Name & Degree
Stephen Choi, MD
First Name & Middle Initial & Last Name & Degree
Patrick Henry, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20936323
Citation
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.
Results Reference
background
PubMed Identifier
15845732
Citation
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.
Results Reference
background
PubMed Identifier
24121609
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs