- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06529393
The Analgesic Effect of (SHAC) Block Versus Suprascapular Nerve Block in Arthroscopic Shoulder Surgeries
The Analgesic Effect of Shoulder Anterior Capsule (SHAC) Block Versus Suprascapular Nerve Block in Arthroscopic Shoulder Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The role of shoulder arthroscopy in the diagnosis and treatment of shoulder disorders is evolving .
Advances in modern arthroscopy have contributed significantly to greater flexibility and efficacy in addressing shoulder pathology.Advantages of arthroscopy include less invasive approaches, improved visualization, decreased risk of many postoperative complications ,and faster recovery.
Shoulder surgery is well recognised as having the potential to cause severe postoperative pain.The aim of this review is to assess critically the evidence relating to the effectiveness of regional anaesthesia techniques commonly used for postoperative analgesia following shoulder surgery opioid analgesics are commonly used for analgesia when nerve block are not used. opoids are effective in relieving postoperative pain at rest but may increase postoperative nausea and vomiting (PONV),somnolence,constipation,urinary retention,respiratory depression ,and sleep disturbances.
supplementing general anesthesia (GA) with a regional nerve block might improve the quality of postoperative relief pain .
Throughout intraoperative and postoperative period, nerve blocks have been used more populary than others because of efficacy.For the regional nerve block,local anesthetic should be infiltrated close to the nerve for maximum effect.
Shoulder anterior capsule block (SHAC):is combination of two different blocks .the first block is the interfascial space between the deep layer of the deltoid fascia and the superficial layer of the subscapularis fascia , anterior to the subscapularis myotendinous junction . Thanks to this interfascial space,we can reach both the axillary nerve and the subscapular nerves,the lateral pectoral nerve and the musculocutaneous nerve.
Suprascapular nerve block(SSB) :The suprascabular nerve (SSN) originates from the nerve roots and provides sensation for the posterior shoulder capsule, acromioclavicular joint,subacromial bursa,and coracoclavicular ligament .Blocking it provides pre-emptive anesthesia , decreased intraoperative pain ,and postoperative pain relief in shoulder arthroscopy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rana EA Ibrahim, Resident
- Phone Number: 00201069626195
- Email: relsayed324@gmail.com
Study Contact Backup
- Name: Ayman M Abdel Khalek, Ass professor
- Phone Number: 00201025675901
- Email: Aymanglala@aun.edu.eg
Study Locations
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Assiut, Egypt
- New Trauma Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- -Age between 18-65 years.
- Body mass index (BMI)of 18-35Kg /m2.
- Patients with American society of anesthesiologist (ASA) physical status | / ||.
- Patients scheduled for elective Arthroscopic Shoulder Surgery.
- Both sexes, males and females.
Exclusion Criteria:
- -Patient refusal.
- Allergy to local anaesthetics.
- Infection at the site of injection .
- Coagulopathy.
- Chronin pain syndromes.
Prolonged opioid medication
.-Patients who received any analgesia 24 h before surgery.
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: SHAC block group
For the SHAC block, with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible.
With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia.Once the injection into the fascial space is achieved, the investigators can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle.
By injecting the pericapsular space, the investigators reach the terminal articular branches indistinctly from their origin.
Furthermore, through the Weitbrecht foramen, a natural capsular foramen between the upper and middle glenohumeral ligaments, we also reach the intra-articular space .
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with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible.
With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia.Once the injection into the fascial space is achieved, the investigators can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle.
By injecting the pericapsular space, the investigators reach the terminal articular branches indistinctly from their origin.
Furthermore, through the Weitbrecht foramen, a natural capsular foramen between the upper and middle glenohumeral ligaments, the investigators also reach the intra-articular space .
Other Names:
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Active Comparator: Suprascapular nerve block group
Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine until supraspinatus or infraspinatus muscle contractions were elicited.
Following negative aspiration,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected.
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Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine until supraspinatus or infraspinatus muscle contractions were elicited.
Following negative aspiration,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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effect on postopeartive pain after shoulder arthrscopy
Time Frame: baseline
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the pain intensity assessment at rest and on coughing using Numerical Rating Scale (NRS) This will measure pain intensity from 0 to 10 , 0: no pain 3:mild pain 7:moderate pain 10:severe pain
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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-inceidence of (POVN) 24 hours postoperatively -Block related complications during and after block procedure till 24 hours postoperatively (LAST, pneumohorax and vascular puncture during block procedure)
Time Frame: first 24 hours
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patients complaint from occurrence of nausea and vomiting
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first 24 hours
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-Time of the first opioid request
Time Frame: first 24 hour
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time of the first opioid request , concentration and occurrence of complications (hypotension,bradycardia,itching,urinary retention.)
all over 24 hours postoperatively
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first 24 hour
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-Block related complications during and after block procedure till 24 hours postoperatively (LAST, pneumohorax and vascular puncture during block procedure)
Time Frame: first 24 hours
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occurrence of any complications from technical errors
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first 24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mohamed S Hassanen, professor, Assuit University Hospital
- Principal Investigator: Rana EA Ibrahim, Resident, Assuit University Hospital
- Study Director: Ayman Abdel Khalek, Ass professor, Assuit University Hospital
Publications and helpful links
General Publications
- Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49.
- Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
- Paxton ES, Backus J, Keener J, Brophy RH. Shoulder arthroscopy: basic principles of positioning, anesthesia, and portal anatomy. J Am Acad Orthop Surg. 2013 Jun;21(6):332-42. doi: 10.5435/JAAOS-21-06-332.
- Basat HC, Ucar DH, Armangil M, Guclu B, Demirtas M. Post operative pain management in shoulder surgery: Suprascapular and axillary nerve block by arthroscope assisted catheter placement. Indian J Orthop. 2016 Nov-Dec;50(6):584-589. doi: 10.4103/0019-5413.193474.
- Brenner W, Bohuslavizki KH, Wolf H, Sippel C, Clausen M, Henze E. Radiotherapy with iodine-131 in recurrent malignant struma ovarii. Eur J Nucl Med. 1996 Jan;23(1):91-4. doi: 10.1007/BF01736995.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHAC Block
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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