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Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

Primary Purpose

Acute Pain

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Interscalene brachial plexus block

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Clavicle

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lausanne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interscalene brachial plexus block

Arm Description

Outcomes

Primary Outcome Measures

IV Morphine consumption in phase 1 recovery (mg)

morphine administered in postanaesthetic care unit by nursers if pains score > 3/10, per protocol

Secondary Outcome Measures

Pain scores at rest and on movement (numeric rating scale, 0-10)

Postoperative nausea and vomiting (yes/no)

Itching (yes/no)

Cumulative oxycodone consumption (mg)

Full Information

NCT ID

NCT02565342

First Posted

September 28, 2015

Last Updated

September 26, 2016

Sponsor

Centre Hospitalier Universitaire Vaudois

1. Study Identification

Unique Protocol Identification Number

NCT02565342

Brief Title

Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

Official Title

Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain

Keywords

Clavicle

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interscalene brachial plexus block

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Interscalene brachial plexus block

Primary Outcome Measure Information:

Title

IV Morphine consumption in phase 1 recovery (mg)

Description

morphine administered in postanaesthetic care unit by nursers if pains score > 3/10, per protocol

Time Frame

0-2 hours after surgery

Secondary Outcome Measure Information:

Title

Pain scores at rest and on movement (numeric rating scale, 0-10)

Time Frame

Postoperative day 0 and 1

Title

Postoperative nausea and vomiting (yes/no)

Time Frame

Postoperative day 0 and 1

Title

Itching (yes/no)

Time Frame

Postoperative day 0 and 1

Title

Cumulative oxycodone consumption (mg)

Time Frame

up to postoperative day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Lausanne University Hospital

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

32312249

Citation

Olofsson M, Taffe P, Kirkham KR, Vauclair F, Morin B, Albrecht E. Interscalene brachial plexus block for surgical repair of clavicle fracture: a matched case-controlled study. BMC Anesthesiol. 2020 Apr 20;20(1):91. doi: 10.1186/s12871-020-01005-x.

Results Reference

derived

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Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

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