Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202112715272407 Date of Approval: 22/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between suprascapular nerve block combined with axillary nerve block and interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy
Official scientific title Comparison between suprascapular nerve block combined with axillary nerve block and interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy
Brief summary describing the background and objectives of the trial Background: Inter-scalene brachial plexus block (ISB) is the gold standard for post-operative pain managements in shoulders surgical operation. Although, this method had side-effects and possibly critical complications. The current work aimed to match ISB with the choosy blockade of supra-scapular and axillary nerve (Shoulder block “ShB”) for post-operative analgesia afterward shoulders arthroscopic surgical operation directed by ultrasound (US) and nerve stimulators. The aim of this study was to compare Interscalene brachial plexus block ISB with the selective blockade of suprascapular and axillary nerves (ShB) for postoperative analgesia after shoulder arthroscopic surgery guided with ultrasound and nerve stimulator.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/04/2018
Actual trial start date 05/04/2018
Anticipated date of last follow up 05/03/2019
Actual Last follow-up date 10/03/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy 10-30 ml of Bupivicaine 0.5% 10-30 minutes 1. Place the ultrasound probe in the supraclavicular fossa in a transverse orientation, aimed caudad into the thoracic cavity, to visualize the brachial plexus near the subclavian artery. Once identified, follow the plexus cephalad where it is found in the interscalene groove. 2. At the interscalene groove, the plexus is typically seen as multiple anechoic circular structures that have a "stoplight" appearance. Typically, the topmost structure is C5 while the middle and lower structures are both C6 as it divides. 3. Use color doppler to identify any vascular structures which may be in the needle path. 4. Insert a block needle in-plane from posterior to anterior and lateral to medial toward the interscalene groove. Be cautious not to advance the needle between any of the hypoechoic nerve roots. 5. Once the needle tip is in the groove, confirm it is not intravascular by negative aspiration. 6. Inject 1 mL to 2 mL of local anesthetic to verify tip placement and spread of local anesthetic into the interscalene groove, causing spread around the nerve roots. 7. Once placement is confirmed, repeat incremental injection and negative aspiration until an adequate spread of local anesthetic has occurred. Typically this is between 10 mL to 30mL. 25 Active-Treatment of Control Group
Experimental Group Shoulder block Combined Suprascapular n.b. with axillary n.b. around 10 ml of bupivacaine 0.5% for each block 10-30 minutes Suprascapular nerve block was performed with the patient sitting and his arm fl exed at the elbow and resting on his anterior thigh. After skin sterilization, a linear ultrasound probe (7–13 MHz frequency) was placed in a sagittal plane at the superior medial border of the scapula. Th e probe was moved laterally and then placed parallel to the scapular spine. It was then tilted cephaled to identify the scapular fossa where the supraspinatus muscle and the bony fossa under it can be visualized. Th en by moving the transducer slowly laterally, the suprascapular notch can be identifi ed where the suprascapular nerve can be seen as a round hypoechoic structure about 4 cm in depth behind the transverse scapular ligament. Two milliliters of 1% lidocaine was used to anesthetize the skin, and then a 22-G 10-cm nerve block needle (B. Braun Medical Inc.) (connected to a peripheral nerve stimulator) was inserted in plane with the ultrasound probe. When the needle tip was seen in the suprascapular notch and after confi rmation of absence of vascular structure by color Doppler, a current less than 0.5 mA produces contraction of deltoid muscle or supraspinatous and infraspinatous muscles, 7–10 ml of 0.5% bupivacaine was injected with aspiration every 3 ml to avoid intravascular injection and the spread of the local anesthetic was observed Axillary nerve block: this was performed while the patient was still in the sitting position with the shoulder adducted and internal rotation at 45°, the elbow flexed at 90° and the hand resting on the knee. Th e probe was placed parallel to the shaft of the humerus and about 2 cm below the posterolateral part of the acromion on the dorsal side of the arm. Th e surgical neck of the humerus was identified, and then a short-axis view of the circumflex artery (which is the most reliable land mark) was visualized. Th e axillary nerve is located just cranial to the circumflex artery in the neurovascular space between the teres minor muscle super 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients aged between 18 – 60 years’ old • Both sexes • Physical Status: ASA I and II Patients • Refusal of procedure or participation in the study • Patient under age of 18 years old or above 60 years’ old • Physical status: ASA III or above • Body weight less than 60 kg or above 100 kg • Pregnancy or lactation • Infection at site of injection • Psychiatric illness • CNS Diseases like (epilepsy, stroke …etc.) or neurological disease affecting patient’s upper limb • History or evidence of coagulopathy • Allergies to drug used (Bupivacaine 0.5%) • Difficult visualization of the anatomy • Recorded failure of block 30 minutes after injection of LA. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/04/2018 Research ethics committee faculty of medicine Ainshams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia square, next to elnour mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Degree of patient satisfaction in each group 0, 2, 4, 8, 16 and 24 hours postoperative
Primary Outcome Comparison between Interscalene brachial plexus block ISB with the selective blockade of suprascapular and axillary nerves (ShB) for postoperative analgesia after shoulder arthroscopic surgery guided with ultrasound and nerve stimulator 0, 2, 4, 8, 16 and 24 hours postoperative
Secondary Outcome Intraoperative doses of different anesthetic drugs in comparison with the regular doses used in the same surgery without block along the operation
Secondary Outcome postoperative different complications 0, 2, 4, 8, 16 and 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ainshams University Abbasya square, Emtedad Ramsis street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahmoud Said Ahmed Attia Elbermway 4A El Nasr Road, Nasr city Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ainshams University 38 abbasia square next to Alnour mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Rania Magdy Mohamed Aly 34 abbasya square, emtedad ramsis Cairo 1181 Egypt
Mostafa Gamale Eldiene Ahmed Mahran 34 abbasya square, emtedad ramsis Cairo 1181 Egypt
Sherif Farouk Ibrahim Elshantory 34 abbasya square, emtedad ramsis Cairo 1181 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Elbermawy mahmoudelbermawy@med.asu.edu.eg 00201022550012 Abbasya square, Emtedad Ramsis street
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Assistant lecturer of anasethisology ICU medicine and pain management
Role Name Email Phone Street address
Scientific Enquiries Rania Magdy rania_m_ismail@yahoo.com 00201001230545 38 Abbasia square
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anaesthiology ICU and pain management
Role Name Email Phone Street address
Public Enquiries Sherif Farouk sherifibrahim210@yahoo.com 00201099811994 34 Abbasya square, emtedad ramsis st
City Postal code Country Position/Affiliation
Cairo Egypt Professor of anasethiology ICU and pain management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be available upon request from corresponding authors after approval by the sponsors and the study supervisors Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 2 years from the end of the study Anaesthesiologists and Shoulder arthroscpy
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information