- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05439837
Paracoracoid Subscapularis Plane Block Versus Iso Block for Shoulder Surgery for Shoulder Surgery
June 27, 2022 updated by: Amr hamdy Mahmoud, Fayoum University Hospital
Paracoracoid Subscapularis Plane Block Versus Infraclavicular and Subomohoid Block for Shoulder Surgery
Shoulder surgery is the second orthopedic operation cause post operative pain Interscalene block is the standard block for shoulder surgery but it cause phrenic nerve block and diaphragmatic hemipareses Iso block is the block used to block the brachial plexuses cord and suprascapular nerve And paracoracoid subscapularis block supra scapular nerve in supra scapular fosa and axillary nerve as it curves around humeral head
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Two groups Group S for paracoracoid subscapularis block Group I for iso block Twenty patients for para coracoid subscapularis block with ultra sonography 50 mm 22G needle inserted anterior to the fascia and 15ml o.5% bupivicaine injected another twenty patients for iso block a linear probe of ultrasound is placed in the infraclavicular region to identify the cords the needle is inserted 2-3cm superior to the clavicle and advanced in.plane posterior to the clavicle toward the cods and 25ml local anaesthesia is injected
Study Type
Interventional
Enrollment (Anticipated)
40
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 Contact
- Name: Nader M El sirry, Bch
- Phone Number: Fayoum 01009883597
- Email: Naderserry2020@gmail.com
Study Contact Backup
- Name: Omar M Farghaly, MD
- Phone Number: Fayoum 01003130742
- Email: Sydmr1480@gmail.com
Study Locations
-
-
Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt
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Fayoum, Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, Egypt, 63514
- Recruiting
- Fayoum University hospital
-
Contact:
- Hany M Yassin, MD
- Phone Number: +20 1111363602
- Email: hmy00@fayoum.edu.eg
-
-
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
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male or female patient >20year for shoulder surgery American Society of anaesthesiologist physical state 1 to2
Exclusion Criteria:
- refusal of patient Systemic infection Local infection Neurological or respiratory disease
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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Infraclavicular and subomohoid block
|
Its blockade of subscapular nerve in the subscapular fossa and axillary nerve as it curves around humeral And blocking of brachial plexuses cord and supra scapular nerve And blocking of the brachial plexuses cord and supra scapular nerve
|
ACTIVE_COMPARATOR: Paracoracoid subscapularis plane block
|
Blocking of suprascapular nerve in supra scapular fossa and axillary nerve as it curves the humeral head
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain assessment by VAS score
Time Frame: At 48 hours postoperative
|
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
|
At 48 hours postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammed A Shawky, MD, Fayoum university hodpital
- Principal Investigator: Joseph M Botros, MD, Eygpt fayoum university
- Principal Investigator: Maged L Bolus, MD, Fayoum universty hospital
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)
June 14, 2022
Primary Completion (ANTICIPATED)
January 1, 2023
Study Completion (ANTICIPATED)
February 1, 2023
Study Registration Dates
First Submitted
June 22, 2022
First Submitted That Met QC Criteria
June 27, 2022
First Posted (ACTUAL)
June 30, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 30, 2022
Last Update Submitted That Met QC Criteria
June 27, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D 229
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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