- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331237
Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block
October 31, 2017 updated by: Ahmad Muhammad Taha, Healthpoint Hospital
Shoulder Analgesia Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block. A Randomized Controlled Double Blind Study
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Abu Dhabi, United Arab Emirates, 112308
- Recruiting
- Healthpoint Hospital
-
Contact:
- Sabah Zahooruddin
- Phone Number: +971 2 4921304
- Email: s.zahooruddin@healthpoint.ae
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LVS group
interscalene injection
|
scalene block using 5ml of ropivacaine
|
Active Comparator: ISO group
in this group all patients will receive ISO block.
|
ISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hemi-diaphragmatic pariesis
Time Frame: 2-4 hours
|
diaphragmatic caudal displacement will be measured (in cm) with real time ultrasound before the block performance and after the procedure
|
2-4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
analgesic efficacy (block success)
Time Frame: 2-4 hours
|
successful block = pain free (VAS 0) in recovery unit.
VAS will be used to evaluate the pain (0 = pain free, 10= most sever pain)
|
2-4 hours
|
patient satisfaction
Time Frame: 24 hours
|
if the patient is satisfied with the analgesia technique or not
|
24 hours
|
duration of analgesia
Time Frame: 24 hours
|
duration between the block performance and the first requesting of pain killer (morphine)
|
24 hours
|
total morphine dose
Time Frame: 24 hours
|
the total morphine consumption within 24 hrs after the block performance
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2017
Primary Completion (Anticipated)
April 1, 2018
Study Completion (Anticipated)
April 1, 2018
Study Registration Dates
First Submitted
October 28, 2017
First Submitted That Met QC Criteria
October 31, 2017
First Posted (Actual)
November 6, 2017
Study Record Updates
Last Update Posted (Actual)
November 6, 2017
Last Update Submitted That Met QC Criteria
October 31, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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