- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05686395
Pain Control After Arthroscopic Shoulder Surgeries
December 16, 2024 updated by: Hosameldin Ibrahim Ibrahim Elsayed Eldib, Tanta University
Comparative Study of Analgesic Efficacy of Ultrasound Guided Interscalene Block Versus Combined Shoulder Anterior Capsular Block and Suprascapular Nerve Block for Arthroscopic Shoulder Surgeries.
This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
90
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
-
-
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Tanta, Egypt
- Faculty of Medicine Tanta University
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-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery.
Exclusion Criteria:
- Patient refusal.
- Uncooperative patient.
- Patient with neurological deficit.
- Patients with respiratory disorders.
- Patient with bleeding disorders.
- Infection at the block injection site.
- Patients with history of allergy to local anesthetics.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group 1 Ultrasound-guided Interscalene Block group
In this group, ultrasound-guided ISB will be done using 10 ml of bupivacaine 0.25%.
|
ultrasound guided interscalene block versus combined ultrasound guided shoulder anterior capsular block and suprascapular nerve block for arthroscopic shoulder surgery
bupivacaine 0.25%.
|
|
Active Comparator: group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
, ultrasound-guided SHAC block will be done using 10 ml of bupivacaine 0.25% injected in the interfacial plane between deltoid and subscapular muscle and 10 ml of bupivacaine 0.25% injected in the pericapsular space.
Ultrasound-guided SSN block will be done using 10 ml of bupivacaine 0.25% injected at sub omohyoid space.
|
bupivacaine 0.25%.
Procedure: Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post operative analgesic consumption
Time Frame: 24 hours after surgery
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The first 24 hours post operative analgesic consumption
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24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue score (VAS) in the first 24 hours after surgery
Time Frame: first 24 hours after surgery
|
- Postoperative pain intensity will be assessed in the first 24 hour using VAS score where (0 = no pain and 100 = the worst imaginable pain)
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first 24 hours after surgery
|
|
Patient satisfaction score
Time Frame: first 24 hours after surgery
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Patient satisfaction score will be assessed on the basis of a questionnaire and graded on a 4-point scale (excellent/good/fair/poor).
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first 24 hours after surgery
|
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The incidence of hemi diaphragmatic paralysis
Time Frame: immediately before block and immediately after procedure
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hemidiaphragmatic paralysis after block
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immediately before block and immediately after procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 23, 2023
Primary Completion (Actual)
August 11, 2024
Study Completion (Actual)
August 11, 2024
Study Registration Dates
First Submitted
January 6, 2023
First Submitted That Met QC Criteria
January 13, 2023
First Posted (Actual)
January 17, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 16, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB0010038
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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