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NCT02565342 Clinical Trial

Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

Acute Pain Clinical Trial

Official title:
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02565342
Other study ID # CER 317/15
Secondary ID
Status Completed
Phase Phase 4
First received September 28, 2015
Last updated September 26, 2016
Start date September 2015
Est. completion date August 2016

Study information
Verified date September 2016
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority Switzerland: Laws and standards
Study type Interventional

Clinical Trial Summary

The sensory innervation of the clavicle remains an area of debate. Regional nerve blocks aimed at relieving pre- and post-operative pain include the superficial cervical plexus blocks, interscalene blocks and a combined version of the above. In this case study, the investigators aim to describe the protocol used in a university hospital: general anaesthesia with interscalene brachial plexus block, followed by optional iv morphine administration in phase 1 recovery and oral oxycodone on the ward.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- clavicular fracture with internal reduction

- physical status I - III

Exclusion Criteria:

- contraindication to regional anaesthesia

- history of neck radiotherapy

- patient suffering from chronic pain

- severe respiratory disease

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Interscalene brachial plexus block

Locations
Country Name City State
Switzerland Lausanne University Hospital Lausanne Vaud

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary IV Morphine consumption in phase 1 recovery (mg) morphine administered in postanaesthetic care unit by nursers if pains score > 3/10, per protocol 0-2 hours after surgery No
Secondary Pain scores at rest and on movement (numeric rating scale, 0-10) Postoperative day 0 and 1 No
Secondary Postoperative nausea and vomiting (yes/no) Postoperative day 0 and 1 No
Secondary Itching (yes/no) Postoperative day 0 and 1 No
Secondary Cumulative oxycodone consumption (mg) up to postoperative day 1 No
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