- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06396455
Ultrasound Guided Suprascapular Nerve Block Versus ISB Block in Arthroscopic Shoulder Surgery
A Comparison Between Ultrasound Guided Suprascapular Nerve Block Versus Ultrasound Guided Interscalene Brachial Plexus Block on Respiratory Mechanics in Patients Undergoing Arthroscopic Shoulder Surgery: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery has high incidence reaching up to 45%; it is often significant enough to interfere with initial recovery and rehabilitation.
Shoulder arthroscopy is becoming more common, representing the second most common Orthopedic surgery after knee arthroscopy . Interscalene brachial plexus block (ISB) is the gold standard analgesic technique for shoulder surgeries with success rates of 87% to 100%, but it also blocks the phrenic nerve (C3-C5).
Suprascapular nerve block via the anterior approach (SSB-A) is performed distally at the trunk/division level of the brachial plexus, thereby potentially sparing the phrenic nerve and minimising many adverse effects of ISB
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Banha, Egypt, 13511
- Benha University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged (18-65 years)
- American Society of Anesthesiologists (ASA) physical status I or II
- scheduled for elective arthroscopic shoulder surgery
Exclusion Criteria:
- pre-existing respiratory,
- cardiac, renal, neurological, or hepatic disease, neuropathy affecting brachial plexus
- contraindication to peripheral nerve block (e.g., coagulopathy),
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: interscalene block group
patients received an ultrasound guided interscalene approach of brachial plexus plane block
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The ISB group scanning was done by linear ultrasound probe just below the level of the cricoid cartilage medial to the sternocleidomastoid muscle; the skin was disinfected, and the transducer was positioned in the transverse plane to identify the carotid artery.
Once the artery was identified, the transducer was moved slightly laterally across the neck to identify the scalene muscles and the brachial plexus that is present between the anterior and middle scalene muscles.
3 ml lidocaine 1% was injected at puncture site The needle was then inserted in-plane toward the brachial plexus, in a lateral-to-medial direction.
After a careful aspiration, 20 ml of bupivacaine 0.25% was injected.
Other Names:
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Experimental: suprascapular nerve block group
patients received ultrasound guided suprascapular nerve block.
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After cleaning the skin with an antiseptic solution, an ultrasound probe was put in sagittal orientation at the superior medial border of the scapula to identify the pleura and then moved laterally; when it was parallel to the spine of the scapula, the transducer was moved cephalad and the suprascapular fossa was identified, and then the transducer was moved lateral to locate the suprascapular notch.
The suprascapular nerve was a round hyperechoic structure beneath the transverse scapular ligament in the scapular notch.
3 ml lidocaine 1% was injected at puncture site then the needle was inserted along the longitudinal axis of the ultrasound beam, and 10 ml of bupivacaine 0.25% was injected.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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visual analogue score
Time Frame: Postoperative pain was assessed using VAS at Postoperative care unit, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24hours after block administration postoperatively
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The visual analogue score (VAS) was used (0 indicating no pain and 10 indicating worst unbearable pain) at rest and upon flexion for assessment of pain intensity upon arrival to the PACU
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Postoperative pain was assessed using VAS at Postoperative care unit, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24hours after block administration postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient satisfaction
Time Frame: 24 hours postoperatively
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Patient satisfaction was evaluated using 5-point Likert scale) (1=extremely dissatisfied; 5=extremely satisfied)
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24 hours postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ramy Saleh, MD, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RC 16-1-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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