Recruiting

Interscalene vs. Superficial Cervical Block

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT03094481

Conditions

Clavicle Fracture

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SCPB

ISB

SCPB + ISB

Bupivacaine hydrogen chloride , epinephrine

Study Details

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.

Conditions

Clavicle Fracture

Study ID

NCT03094481

Start date

Oct 21, 2016

Status verified date

May, 2018

Completion date

Mar 1, 2020

Anticipated

Primary completion date

Nov 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: US guided SCPB medial fracture

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.

active comparator: US guided ISB medial fracture

Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.

active comparator: US guided SCPB + ISB medial fracture

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.

active comparator: US guided SCPB lateral fracture

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.

active comparator: US guided ISB lateral fracture

Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.

active comparator: US guided SCPB + ISB lateral fracture

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.

Interventions

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.

Bupivacaine hydrogen chloride , epinephrine

Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine

Primary outcome measure

  • Pain measurement using NRS in PACU [ Time Frame: 1 hour post-op ]

Central Contacts and Locations

Central contacts

Paul McHardy, MD, FRCPC

4164804864paul.mchardy@sunnybrook.ca

Shelly Au, PhD, PMP

4164806100shelly.au@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Paul McHardy, MD

416-480-6100paul.mchardy@sunnybrook.ca

Principal Investigator:

Paul McHardy, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 3, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2018-05-03.