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

Clavicle Fracture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03094481
• Other study ID #: 036-2016
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

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