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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2016
CompletedFirst Submitted
Initial submission to the registry
March 15, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMay 3, 2018
May 1, 2018
3 years
March 15, 2017
May 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Pain measurement using NRS in PACU
Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit
1 hour post-op
Secondary Outcomes (3)
Pain measurement using NRS at Discharge
4 hours post-op
Opioid consumption in morphine equivalence
4 hours post-op
Satisfaction using rating scale
4 hours post-op
Study Arms (6)
US guided SCPB medial fracture
ACTIVE COMPARATORBupivacaine 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
ACTIVE COMPARATORBupivacaine 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
ACTIVE COMPARATORBupivacaine 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
ACTIVE COMPARATORBupivacaine 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
ACTIVE COMPARATORBupivacaine 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
ACTIVE COMPARATORBupivacaine 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.
Interventions
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.
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 Inj 0.5% (1:200,000) epinephrine
Eligibility Criteria
You may qualify if:
- undergoing open reduction and internal fixation of clavicle fracture (midshaft or lateral)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (3)
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.
PMID: 20936323BACKGROUNDChoi 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.
PMID: 15845732BACKGROUNDTran 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.
PMID: 24121609BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul McHardy, MD, FRCPC
Sunnybrook Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Staff Anesthesiologist
Study Record Dates
First Submitted
March 15, 2017
First Posted
March 29, 2017
Study Start
October 21, 2016
Primary Completion
November 1, 2019
Study Completion
March 1, 2020
Last Updated
May 3, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share