Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block
Shoulder Analgesia Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block. A Randomized Controlled Double Blind Study
1 other identifier
interventional
72
1 country
1
Brief Summary
For shoulder analgesia, both ISO block and low volume scalene (LVS) block (using 5 ml of local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis (HDP). The aim of this study was to compare the incidence of HDP and the analgesic efficacy of the LVS block versus ISO block.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
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
October 9, 2017
CompletedFirst Submitted
Initial submission to the registry
October 28, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedNovember 6, 2017
October 1, 2017
6 months
October 28, 2017
October 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
hemi-diaphragmatic pariesis
diaphragmatic caudal displacement will be measured (in cm) with real time ultrasound before the block performance and after the procedure
2-4 hours
Secondary Outcomes (4)
analgesic efficacy (block success)
2-4 hours
patient satisfaction
24 hours
duration of analgesia
24 hours
total morphine dose
24 hours
Study Arms (2)
LVS group
ACTIVE COMPARATORinterscalene injection
ISO group
ACTIVE COMPARATORin this group all patients will receive ISO block.
Interventions
ISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture
Eligibility Criteria
You may qualify if:
- patients who were scheduled for arthroscopic shoulder surgery
You may not qualify if:
- aged \<18y
- BMI \>35,
- ASA greater \>III,
- an infection at the injection site
- has a contraindication for laryngeal mask or the medications used in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Healthpoint Hospital
Abu Dhabi, 112308, United Arab Emirates
Related Publications (1)
Taha AM, Yurdi NA, Elahl MI, Abd-Elmaksoud AM. Diaphragm-sparing effect of the infraclavicular subomohyoid block vs low volume interscalene block. A randomized blinded study. Acta Anaesthesiol Scand. 2019 May;63(5):653-658. doi: 10.1111/aas.13322. Epub 2019 Jan 30.
PMID: 30697688DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant of aneathesia
Study Record Dates
First Submitted
October 28, 2017
First Posted
November 6, 2017
Study Start
October 9, 2017
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
November 6, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share