Clavicle Fracture
Conditions
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).
Interventions
PROCEDURESCPB
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.
PROCEDUREISB
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.
PROCEDURESCPB + 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.
DRUGBupivacaine hydrogen chloride , epinephrine
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain measurement using NRS in PACU | 1 hour post-op | Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction using rating scale | 4 hours post-op | Patient satisfaction with postoperative analgesia at time of discharge |
| Pain measurement using NRS at Discharge | 4 hours post-op | Numeric Rating Scale for Pain upon discharge from hospital |
| Opioid consumption in morphine equivalence | 4 hours post-op | Total postoperative opioid consumption from end of operation to hospital discharge |
Countries
Canada
Contacts
Primary ContactPaul McHardy, MD, FRCPC
Backup ContactShelly Au, PhD, PMP
Outcome results
None listed