Clinical trial NCT03094481: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Clavicle Fracture
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Pain measurement using NRS in PACU
timeFrame: 1 hour post-op
Secondary outcomes:
measure: Pain measurement using NRS at Discharge
timeFrame: 4 hours post-op
measure: Opioid consumption in morphine equivalence
timeFrame: 4 hours post-op
measure: Satisfaction using rating scale
timeFrame: 4 hours post-op
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Paul McHardy, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.