- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07649460
Shoulder Anterior Capsule Block Combined With Supra Scapular Nerve Versus Interscalene Block as Sole Anesthesia in Shoulder Arthroscopy
Shoulder Anterior Capsule Block Combined With Suprascapular Nerve Block Versus Interscalene Block as a Sole Anesthetic Technique for Shoulder Arthroscopy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ultrasonographic peripheral nerve block has been a popular technique not only for pain management but also for surgical anesthesia especially in patients with comorbidities, avoiding complications associated with general anesthesia (airway-difficulties, hemodynamic instability, etc.) and ensuring excellent pain control, reducing peri-operative consumption of opioids and their side effects, and improving patient satisfaction.
Interscalene block (ISB) is the gold stander anesthetic technique for shoulder surgeries but hemi-diaphragmatic paralysis still problematic. The SHAC is the combination of two different blocks. The first block is the inter fascial space between the deep layer of the deltoid fascia and the superficial layer of the subscapularis fascia, anterior to the subscapularis myotendinous junction. This inter fascial space, we can reach both the axillary nerve and the subscapular nerves, the lateral pectoral nerve, and the musculocutaneous nerve results in achieving adequate anesthesia and analgesia without phrenic nerve affection.
The present study will be conducted to compare of SHAC block combined with suprascapular nerve block and Interscalene block as an anesthetic option in shoulder arthroscopic surgery may allow adequate postoperative analgesia and decrease the overall opioid usage and enhanced patient recovery
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sharqia Province
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Zagazig, Sharqia Province, Egypt
- Zagazig university hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written informed consent from patients.
- BMI less than or equal 30 kgm .
- Age 18-75 years old.
- ASA class I, II and III.
Exclusion Criteria:
- Allergy to local anesthetics.
- Infection at site of injection.
- Patients with coagulopathy.
- Physical and mental disease which could interfere with pain scores evaluation.
- pre-existing neuropathy of the operative limb.
- Pre-existing sever pulmonary diseases (obstructive or restrictive).
- Patients with distorted local anatomy.
Patients with chronic pain syndrom
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group SHAC block
Group SHAC block: Patients will receive Ultrasound Guided Shoulder Anterior Capsule block and Suprascapular nerve block
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Group SHAC block: Patients will receive Ultrasound Guided Shoulder Anterior Capsule block and Suprascapular nerve block
|
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Active Comparator: Group IS block
Group IS block: Patients will receive Ultrasound Guided interscalene brachial plexus block.
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Group IS block: Patients will receive Ultrasound Guided interscalene brachial plexus block.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by using Visual Analogue Scale (VAS)
Time Frame: From start of surgery and for the 1st 24 hours postoperatively.
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Inter-operative VAS immediately after the block and every 5 minutes for 30 minutes and every 2 hours post-operatively for 24 hours while 0 indicates no pain and 10 the severest pain.
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From start of surgery and for the 1st 24 hours postoperatively.
|
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by duration of analgesia
Time Frame: 24 hours postoperatively
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by duration of analgesia.
Duration of postoperative analgesia (from the time of patient recovery till the time of rescue analgesia).
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24 hours postoperatively
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by amount of opioid consumption postoperatively.
Time Frame: 1st 24 hours postoperatively.
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by amount of opioid consumption postoperatively.
Total dose of morphine per mg used during the 1st 24 hours postoperatively.
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1st 24 hours postoperatively.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Safety of SHAC block by monitoring of complications eg. local anesthetic toxicity , hemodynamics instability, phrenic nerve affection, pneumothorax.
Time Frame: From start of surgery and for the 1st 24 hours.
|
Monitoring of complications like local anesthetic toxicity ( restlessness, irritability, confusion, convulsions and arrhythmias) hemodynamics instability, phrenic nerve affection ( diaphragmatic paralysis) , pneumothorax ( decrease in oxygen saturation monitoring, tachypnea, diminished air entry on affected side by auscultation).
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From start of surgery and for the 1st 24 hours.
|
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Patient satisfaction with the anesthesia and analgesia during and after surgery
Time Frame: From start of surgery and for the 1st 24 hours postoperatively.
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Patient satisfaction was evaluated by using satisfaction score and patients were graded on a 5-point scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied, and assessed at 24 h post-operation
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From start of surgery and for the 1st 24 hours postoperatively.
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Collaborators and Investigators
Sponsor
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 387/10 - june-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
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