Clavicle FractureNCT03094481
Interscalene vs. Superficial Cervical Block vs. Combination for Analgesia After Clavicle Fracture
A study testing SCPB, ISB and SCPB + ISB in people with Clavicle Fracture, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- SCPB, ISB and SCPB + ISB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 21 Oct 2016to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing open reduction and internal fixation of clavicle fracture (midshaft or lateral)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Paul McHardy, MD, 416-480-6100 ext. pg x 6626, paul.mchardy@sunnybrook.ca
Paul McHardy, MD
About this study
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
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.
Read the 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).
- Conditions
- Clavicle Fracture
- Being tested
- SCPB, ISB, SCPB + ISB, Bupivacaine hydrogen chloride , epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCPBProcedure or surgery
Also called Superficial Cervical Plexus
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.
ISBProcedure or surgery
Also called Interscalene Brachial Plexus
Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.
SCPB + ISBProcedure or surgery
Also called Superficial Cervical Plexus & Interscalene Brachial Plexus
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 , epinephrineDrug
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine
| Study group | Role | What they receive |
|---|---|---|
| US guided SCPB medial fracture | Active comparator | Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. Receives: Procedure: SCPB; Drug: Bupivacaine hydrogen chloride , epinephrine |
| US guided ISB medial fracture | Active comparator | Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6. Receives: Procedure: ISB; Drug: Bupivacaine hydrogen chloride , epinephrine |
| US guided SCPB + ISB medial fracture | Active comparator | Bupivacaine 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. Receives: Procedure: SCPB + ISB; Drug: Bupivacaine hydrogen chloride , epinephrine |
| US guided SCPB lateral fracture | Active comparator | Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. Receives: Procedure: SCPB; Drug: Bupivacaine hydrogen chloride , epinephrine |
| US guided ISB lateral fracture | Active comparator | Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6. Receives: Procedure: ISB; Drug: Bupivacaine hydrogen chloride , epinephrine |
| US guided SCPB + ISB lateral fracture | Active comparator | Bupivacaine 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. Receives: Procedure: SCPB + ISB; Drug: Bupivacaine hydrogen chloride , epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement using NRS in PACU
Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit
Measured: 1 hour post-op
Secondary outcomes (3)
Pain measurement using NRS at Discharge
Numeric Rating Scale for Pain upon discharge from hospital
Measured: 4 hours post-op
Opioid consumption in morphine equivalence
Total postoperative opioid consumption from end of operation to hospital discharge
Measured: 4 hours post-op
Satisfaction using rating scale
Patient satisfaction with postoperative analgesia at time of discharge
Measured: 4 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start21 Oct 2016
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul McHardy, Sunnybrook Health Sciences Centre
- Investigators
- Paul McHardy, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094481
- Sponsor's protocol ID
- 036-2016
- Status last verified
- May 2018
- First submitted
- 15 Mar 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20936323Choi 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.
PubMed 15845732Tran 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.
PubMed 24121609
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03094481
- Acronym / sponsor ID
- 036-2016
- Conditions
- Clavicle Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| US guided SCPB medial fracture | Active comparator | Procedure: SCPB, Drug: Bupivacaine hydrogen chloride , epinephrineBupivacaine 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 comparator | Procedure: ISB, Drug: Bupivacaine hydrogen chloride , epinephrineBupivacaine 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 comparator | Procedure: SCPB + ISB, Drug: Bupivacaine hydrogen chloride , epinephrineBupivacaine 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 comparator | Procedure: SCPB, Drug: Bupivacaine hydrogen chloride , epinephrineBupivacaine 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 comparator | Procedure: ISB, Drug: Bupivacaine hydrogen chloride , epinephrineBupivacaine 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 comparator | Procedure: SCPB + ISB, Drug: Bupivacaine hydrogen chloride , epinephrineBupivacaine 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing open reduction and internal fixation of clavicle fracture (midshaft or lateral)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCPBAlso: Superficial Cervical PlexusBupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5. | Procedure or surgery | US guided SCPB lateral fracture, US guided SCPB medial fracture |
| ISBAlso: Interscalene Brachial PlexusBupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6. | Procedure or surgery | US guided ISB lateral fracture, US guided ISB medial fracture |
| SCPB + ISBAlso: Superficial Cervical Plexus & Interscalene Brachial PlexusBupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided SCPB at C4 or C5 + 10ml injected for ISB at C5 or C6. | Procedure or surgery | US guided SCPB + ISB lateral fracture, US guided SCPB + ISB medial fracture |
| Bupivacaine hydrogen chloride , epinephrineBupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine | Drug | US guided ISB lateral fracture, US guided ISB medial fracture, US guided SCPB + ISB lateral fracture, US guided SCPB + ISB medial fracture, US guided SCPB lateral fracture, US guided SCPB medial fracture |
Primary outcome
Pain measurement using NRS in PACU
Time frame: 1 hour post-op
Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit
3 secondary outcomes
Pain measurement using NRS at Discharge
Time frame: 4 hours post-op
Opioid consumption in morphine equivalence
Time frame: 4 hours post-op
Satisfaction using rating scale
Time frame: 4 hours post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 20936323Faldini 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.
- Background: PubMed 15845732Choi 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.
- Background: PubMed 24121609Tran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul McHardy, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCPB, ISB and SCPB + ISB in people with Clavicle Fracture, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul McHardy, MD, FRCPC (4164804864, paul.mchardy@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measurement using NRS in PACU (time frame: 1 hour post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094481, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.