NCT02565342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

September 28, 2015

Last Update Submit

September 26, 2016

Conditions

Keywords

Clavicle

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

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

    Postoperative day 0 and 1

  • Postoperative nausea and vomiting (yes/no)

    Postoperative day 0 and 1

  • Itching (yes/no)

    Postoperative day 0 and 1

  • Cumulative oxycodone consumption (mg)

    up to postoperative day 1

Study Arms (1)

Interscalene brachial plexus block

EXPERIMENTAL
Procedure: Interscalene brachial plexus block

Interventions

Interscalene brachial plexus block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clavicular fracture with internal reduction
  • physical status I - III

You may not qualify if:

  • contraindication to regional anaesthesia
  • history of neck radiotherapy
  • patient suffering from chronic pain
  • severe respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Regional Anaesthesia

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 1, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations