Distant Extrafascial Injection vs Subfascial Injection for Interscalene Block: Acute Pain Outcomes and Rates of Complications
1 other identifier
interventional
40
1 country
1
Brief Summary
The objective of this randomized controlled trial is to compare the analgesic efficacy and the safety profile between two techniques of injection for the interscalene block. The interscalene block consists of injecting local anesthetic around the cervical roots of the brachial plexus and allows analgesia after shoulder surgery. Stated differently, the dual objective of that study is:
- 1.to confirm that an injection at a distance of 4 mm away from the lateral sheath of the plexus (distal injection) provides similar analgesia as a classical injection within the plexus (subfascial injection);
- 2.to demonstrate that a distant extrafascial injection produces less respiratory complications than a subfascial injection, defined as hemidiaphragmatic paresis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMarch 2, 2020
February 1, 2020
1.2 years
February 26, 2014
February 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of success block defined as complete motor and sensory block on C5-C6 territories
30 minutes after block procedure
Rate of hemidiaphragmatic paresis, assessed with the ultrasound
30 minutes after block procedure
Study Arms (2)
Distant extrafascial injection
EXPERIMENTALInjection away from the brachial plexus with the needle tip positioned in the middle scalene muscle
Subfascial injection
ACTIVE COMPARATORInjection within the brachial plexus, with the needle tip positioned between C5 and C6
Interventions
Eligibility Criteria
You may qualify if:
- ASA (American Society of Anesthesiology) physical status I-II
- years of age
- surgery less than 3 hours
You may not qualify if:
- indication for continuous interscalene block (catheters)
- contraindications for brachial plexus block (eg allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- existing neurological deficit in the area to be blocked
- history of neck surgery or radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHUV (Centre Hospitalier Universitaire Vaudois)
Lausanne, Canton of Vaud, 1011, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD; program director, regional aneshesia
Study Record Dates
First Submitted
February 26, 2014
First Posted
February 28, 2014
Study Start
February 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
March 2, 2020
Record last verified: 2020-02