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.: PACTR202308722616710 Date of Approval: 07/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound Guided Suprascapular nerve block combined with intra-articular injection of bupivacaine versus ultrasound-guided interscalene nerve block in shoulder arthroscopy.
Official scientific title Ultrasound Guided Suprascapular nerve block combined with intra-articular injection of bupivacaine versus ultrasound-guided interscalene nerve block in shoulder arthroscopy.
Brief summary describing the background and objectives of the trial Shoulder surgery is usually associated with severe postoperative pain (1). The use of arthroscopy is popular because it is associated with less pain, shortens hospital stays, and improves patient satisfaction. However, immediate postoperative pain remains a problem in more than 40% of patients (1,2). The most effective method in controlling postoperative pain in shoulder surgery is regional nerve blocks, such as the interscalene nerve block (ISNB) and the suprascapular nerve block (SSNB) (1,3). In this study, we will evaluate the effectiveness of ultrasound-guided suprascapular nerve block combined with intra-articular injection of bupivacaine versus interscalene nerve block for postoperative analgesia in shoulder arthroscopic surgeries.
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 Education /Training
Anticipated trial start date 01/01/2023
Actual trial start date 10/01/2023
Anticipated date of last follow up 01/04/2023
Actual Last follow-up date 01/06/2023
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Active, not recruiting
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 a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ultrasound guided interscalene nerve block 15 ml of bupivacaine 0.25% 24 hours With the patient in a supine position elevated 45 degrees with the head tilted to the opposite side, the transducer is positioned in the transverse plane to identify the carotid artery. Once the artery has been identified, the transducer is moved slightly laterally across the neck. The goal is to identify the anterior and middle scalene muscles and the elements of the brachial plexus that are located between them. Then we will use the colour Doppler to identify vascular structures and avoid them. The needle will be inserted in a plane toward the brachial plexus, typically in a lateral-to-medial direction. After careful aspiration to rule out intravascular needle placement, 1–2 mL of local anesthetic is injected to verify proper needle placement. Injection of several millilitres of local anesthetic often displaces the brachial plexus away from the needle. Additional advancement of the needle 1–2 mm toward the brachial plexus may be beneficial to ensure a proper spread of the local anesthetic, then 15 ml of bupivacaine 0.25% is injected. 15 Active-Treatment of Control Group
Experimental Group Ultrasound Guided Suprascapular nerve block combined with intra articular injection of bupivacaine 7.5 mL of bupivacaine 0.25% combined with an intra-articular injection of 7.5 ml of bupivacaine 0.25% done by the surgeon 24 hours With the patient in a supine position elevated 45 degrees with the head tilted to the opposite side, the transducer is positioned in a coronal plane over the suprascapular fossa with a slight anterior tilt. Identify the suprascapular nerve on the floor of the scapular spine between the suprascapular notch and spinoglenoid notch. The suprascapular nerve and artery run underneath the fascia of the supraspinatus muscle. Insert the needle in-plane from the medial side of the transducer and inject 7.5 mL of bupivacaine 0.25% combined with an intra-articular injection of 7.5 ml of bupivacaine 0.25% done by the surgeon. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Physical status: ASA I and II. Age: between 21 and 60 years old. Refusal of informed consent for regional anaesthesia. Known Allergy to one of the study drugs. History or evidence of coagulopathy, use of anti-coagulant, anti-platelet therapy, or infection at the injection site. Patients with a history of drug abuse. Patients with a history of upper limb neuronal injury at the same limb of the block. Patients with history of respiratory distress for fear of diaphragmatic paralysis. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 28/03/2023 Research ethics committee faculty of medecine ain shams university
Ethics Committee Address
Street address City Postal code Country
Abbasiya Cairo 2121 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be the time interval after which there will be a requirement of the first supplemental dose of rescue analgesia (Pethidine 50mg IM) with NRS ≥4. 0, 1, 2, 4, 8, 16, 24
Secondary Outcome The secondary outcome is the total dose of pethidine that will be received as rescue analgesia in 1st 24 hours postoperatively, hemodynamics and complications such as nausea, vomiting, and respiratory distress due to diaphragmatic paralysis assessed by chest ultrasound or pneumothorax assessed clinically and by A-P chest X-ray. 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Eldemerdash hospitals. Abbasiya Cairo 2121 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
me Abbasiya Cairo 2121 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medecine Abbasiya Cairo 2121 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Tarek mohamedtarek7820@gmail.com 01015893358 Abbasiya
City Postal code Country Position/Affiliation
Cairo 2121 Egypt Resident Doctor
Role Name Email Phone Street address
Public Enquiries Mostafa Mansour mostafa.mansor@med.asu.edu.eg 01093322145 Abbasiya
City Postal code Country Position/Affiliation
Cairo 2121 Egypt Consultant
Role Name Email Phone Street address
Scientific Enquiries Ayman Abdellatif AymanAbdellatif@gmail.com 201020166199 Abbasiya
City Postal code Country Position/Affiliation
Cairo 2121 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. ( Including text, tables, figures and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date. Anyone who wishes to access the data. for any type of analyses. The data will be available in our university's data warehouse.
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