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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03094481
Other study ID # 036-2016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 21, 2016
Est. completion date March 1, 2020

Study information

Verified date May 2018
Source Sunnybrook Health Sciences Centre
Contact Paul McHardy, MD, FRCPC
Phone 4164804864
Email paul.mchardy@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 1, 2020
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
SCPB
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.
ISB
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.
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.
Drug:
Bupivacaine hydrogen chloride , epinephrine
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine

Locations

Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Choi DS, Atchabahian A, Brown AR. Cervical plexus block provides postoperative analgesia after clavicle surgery. Anesth Analg. 2005 May;100(5):1542-3. — View 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. — View Citation

Tran DQ, Tiyaprasertkul W, González 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain measurement using NRS in PACU Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit 1 hour post-op
Secondary Pain measurement using NRS at Discharge Numeric Rating Scale for Pain upon discharge from hospital 4 hours post-op
Secondary Opioid consumption in morphine equivalence Total postoperative opioid consumption from end of operation to hospital discharge 4 hours post-op
Secondary Satisfaction using rating scale Patient satisfaction with postoperative analgesia at time of discharge 4 hours post-op
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