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Distant Extrafascial Injection vs Subfascial Injection for Interscalene Block: Acute Pain Outcomes and Rates of Complications

NCT02074397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-03-02

No results posted yet for this study

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.

Conditions

  • Ultrasound-guided Regional Anesthesia
  • Shoulder Surgery
  • Interscalene Block
  • Postoperative Analgesia
  • Respiratory Function

Interventions

PROCEDURE

Distant extrafascial injection

PROCEDURE

Subfascial injection

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02074397 on ClinicalTrials.gov