Back to resultsParacoracoid Subscapularis Plane Block Versus Iso Block for Shoulder Surgery for Shoulder Surgery
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Infraclavicular and subomohoid block
Paracoracoid subscapularis plane block
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain
Eligibility Criteria
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
Sites / Locations
- Fayoum University hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Infraclavicular and subomohoid block
Paracoracoid subscapularis plane block
Arm Description
Outcomes
Primary Outcome Measures
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Secondary Outcome Measures
Full Information
NCT ID
NCT05439837
First Posted
June 22, 2022
Last Updated
June 27, 2022
Sponsor
Fayoum University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05439837
Brief Title
Paracoracoid Subscapularis Plane Block Versus Iso Block for Shoulder Surgery for Shoulder Surgery
Official Title
Paracoracoid Subscapularis Plane Block Versus Infraclavicular and Subomohoid Block for Shoulder Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University 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
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infraclavicular and subomohoid block
Arm Type
Active Comparator
Arm Title
Paracoracoid subscapularis plane block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Infraclavicular and subomohoid block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Paracoracoid subscapularis plane block
Intervention Description
Blocking of suprascapular nerve in supra scapular fossa and axillary nerve as it curves the humeral head
Primary Outcome Measure Information:
Title
Pain assessment by VAS score
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
At 48 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nader M El sirry, Bch
Phone
01009883597
Ext
Fayoum
Email
Naderserry2020@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Omar M Farghaly, MD
Phone
01003130742
Ext
Fayoum
Email
Sydmr1480@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Shawky, MD
Organizational Affiliation
Fayoum university hodpital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph M Botros, MD
Organizational Affiliation
Eygpt fayoum university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maged L Bolus, MD
Organizational Affiliation
Fayoum universty hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fayoum University hospital
City
Fayoum
State/Province
Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt
ZIP/Postal Code
63514
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany M Yassin, MD
Phone
1111363602
Ext
+20
Email
hmy00@fayoum.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16510834
Citation
Garrett WE Jr, Swiontkowski MF, Weinstein JN, Callaghan J, Rosier RN, Berry DJ, Harrast J, Derosa GP. American Board of Orthopaedic Surgery Practice of the Orthopaedic Surgeon: Part-II, certification examination case mix. J Bone Joint Surg Am. 2006 Mar;88(3):660-7. doi: 10.2106/JBJS.E.01208. No abstract available.
Results Reference
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Paracoracoid Subscapularis Plane Block Versus Iso Block for Shoulder Surgery for Shoulder Surgery
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