Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

September 26, 2016 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Lausanne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interscalene brachial plexus block
Procedure: Interscalene brachial plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IV Morphine consumption in phase 1 recovery (mg)
Time Frame: 0-2 hours after surgery
morphine administered in postanaesthetic care unit by nursers if pains score > 3/10, per protocol
0-2 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain scores at rest and on movement (numeric rating scale, 0-10)
Time Frame: Postoperative day 0 and 1
Postoperative day 0 and 1
Postoperative nausea and vomiting (yes/no)
Time Frame: Postoperative day 0 and 1
Postoperative day 0 and 1
Itching (yes/no)
Time Frame: Postoperative day 0 and 1
Postoperative day 0 and 1
Cumulative oxycodone consumption (mg)
Time Frame: up to postoperative day 1
up to postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 317/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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