Back to resultsSparing Diaphragm; ISO Block Versus Low Volume Scalene Block
Primary Purpose
Shoulder Arthropathy Associated With Other Conditions
Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
scalene block
ISO block
Sponsored by
About this trial
This is an interventional prevention trial for Shoulder Arthropathy Associated With Other Conditions
Eligibility Criteria
Inclusion Criteria:
- patients who were scheduled for arthroscopic shoulder surgery
Exclusion Criteria:
- 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.
Sites / Locations
- Healthpoint HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LVS group
ISO group
Arm Description
interscalene injection
in this group all patients will receive ISO block.
Outcomes
Primary Outcome Measures
hemi-diaphragmatic pariesis
diaphragmatic caudal displacement will be measured (in cm) with real time ultrasound before the block performance and after the procedure
Secondary Outcome Measures
analgesic efficacy (block success)
successful block = pain free (VAS 0) in recovery unit. VAS will be used to evaluate the pain (0 = pain free, 10= most sever pain)
patient satisfaction
if the patient is satisfied with the analgesia technique or not
duration of analgesia
duration between the block performance and the first requesting of pain killer (morphine)
total morphine dose
the total morphine consumption within 24 hrs after the block performance
Full Information
NCT ID
NCT03331237
First Posted
October 28, 2017
Last Updated
October 31, 2017
Sponsor
Healthpoint Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03331237
Brief Title
Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block
Official Title
Shoulder Analgesia Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block. A Randomized Controlled Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Healthpoint Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthropathy Associated With Other Conditions
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LVS group
Arm Type
Active Comparator
Arm Description
interscalene injection
Arm Title
ISO group
Arm Type
Active Comparator
Arm Description
in this group all patients will receive ISO block.
Intervention Type
Procedure
Intervention Name(s)
scalene block
Intervention Description
scalene block using 5ml of ropivacaine
Intervention Type
Procedure
Intervention Name(s)
ISO block
Intervention Description
ISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture
Primary Outcome Measure Information:
Title
hemi-diaphragmatic pariesis
Description
diaphragmatic caudal displacement will be measured (in cm) with real time ultrasound before the block performance and after the procedure
Time Frame
2-4 hours
Secondary Outcome Measure Information:
Title
analgesic efficacy (block success)
Description
successful block = pain free (VAS 0) in recovery unit. VAS will be used to evaluate the pain (0 = pain free, 10= most sever pain)
Time Frame
2-4 hours
Title
patient satisfaction
Description
if the patient is satisfied with the analgesia technique or not
Time Frame
24 hours
Title
duration of analgesia
Description
duration between the block performance and the first requesting of pain killer (morphine)
Time Frame
24 hours
Title
total morphine dose
Description
the total morphine consumption within 24 hrs after the block performance
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who were scheduled for arthroscopic shoulder surgery
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabah Zahooruddin
Phone
009712 4929000
Ext
1304
Email
s.zahooruddin@helathpoint.ae
Facility Information:
Facility Name
Healthpoint Hospital
City
Abu Dhabi
ZIP/Postal Code
112308
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabah Zahooruddin
Phone
+971 2 4921304
Email
s.zahooruddin@healthpoint.ae
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30697688
Citation
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.
Results Reference
derived
Learn more about this trial
Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block
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