Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 27, 2016
September 1, 2016
11 months
September 28, 2015
September 26, 2016
Conditions
Keywords
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
EXPERIMENTALInterventions
Eligibility Criteria
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
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.
PMID: 32312249DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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