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.: PACTR202201840526231 Date of Approval: 11/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study between ultrasound guided interscalene and suprascapular nerve blocks in postoperative pain and hand motor power affection in shoulderscope surgeries
Official scientific title A Comparative Study between ultrasound guided interscalene and suprascapular nerve blocks in postoperative pain and hand motor power affection in shoulderscope surgeries
Brief summary describing the background and objectives of the trial - Interscalene block provides optimal shoulder surgery analgesia, but concerns over its associated risks have prompted the search for alternatives .Interscalene nerve block has major side effects including phrenic nerve affection which affects respiratory function. Furthermore, interscalene nerve block leads to affection of motor power in the muscles of the hand which leads to patient discomfort - Suprascapular block was recently proposed as an interscalene block alternative. In addition, suprscapular nerve block has shown effective analgesia for both postoperative and chronic shoulder pain.
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: Drugs
Anticipated trial start date 16/01/2021
Actual trial start date 01/07/2021
Anticipated date of last follow up 01/01/2022
Actual Last follow-up date 02/01/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 55
Recruitment status 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 Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Suprascapular block 10 ml of 0.25% Bupivacaine will be injected Before the start of the operation One shot :will receive Suprascapular nerve block which will be performed before induction of general anaesthesia. The ultrasound transducer will be placed in a transverse orientation over the scapular spine, moving the transducer cephalad until identifying the suprascapular fossa . While imaging the supraspinatus muscle and the bony fossa underneath, the ultrasound transducer will be moved laterally (maintaining a transverse transducer orientation) to locate the suprascapular notch. The suprascapular nerve will be seen as a round hyperechoic structure at 4 cm depth beneath the transverse scapular ligament in the scapular notch. 10 ml of 0.25% Bupivacaine will be injected at that location. 25
Control Group Interscalene nerve block 20 ml of 0.25% Bupivacaine Befor the start of the operation One shot will receive ultra-sound guided interscalene block on the same limb of the surgery in the supine position before induction of general anesthesia ,the block will be performed using a high-frequency linear probe placed in interscalene groove . using the lateral modified approach (Meier approach). After negative aspiration ,20 ml of 0.25% Bupivacaine will be injected in-plane under ultrasound guidance with an ultrasound-visible needle. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult, aged 20 - 50 years. American Society of Anesthesiologists (ASA) Physical Status Class-I and II. Scheduled for unilateral shoulderscope surgeries 4 . Body mass index (BMI) < 35 Kg/ m2 . 5-.Informed consent to participate in the study. Refusing to give written informed consent. History of allergy to the medications used in the study. Contraindications to regional anesthesia (including coagulopathy and local infection). Prior surgery in the neck, infraclavicular region or suprascapular fossa. Significant neurological, cardiac, renal, hepatic or respiratory disease . Addiction to narcotics or psycho-active drugs. Chronic pain syndromes requiring opioid intake at home. pre-existing neuropathy (assessed by history and physical examination). Psychiatric disorder. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 55 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 09/01/2021 Ethics research committee faculty of medicine ain shams University
Ethics Committee Address
Street address City Postal code Country
38 el abbasia street near to al nour mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain at rest in the shoulder 0 2 4 6 12 24 h
Primary Outcome pain on movement (flexion) of the shoulder joint 0 2 4 6 12 24 h
Primary Outcome percentage of the decrease in the hand grip strength. 0 2 4 6 12 24
Secondary Outcome : the total amount of pethidine consumed in the first 24 hours postoperatively 24 hours postoperatively
Secondary Outcome The incidence of complications including pneumothorax, vascular injury, respiratory distress and local anesthetic toxicity 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque, Cairo, Egypt Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The principle investigator 1 gabl akdr street nasr city Cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine ain shams University 38 Abbassia Square, Next to Al-Nour Mosque, Cairo, Egypt Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Medhat Mohamed Hashem 1 gabl akdr street nasr city Cairo 11765 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Ahmed drmmedhat.ainshams@gmail.com 0201006049087 1 gabl akdr street nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Assistant lecturer Ain Shams University
Role Name Email Phone Street address
Public Enquiries Noha Mohammed Noham2@outlook.com 011119758252 20nozha street
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Lecturer of anesthetics ain shams University
Role Name Email Phone Street address
Scientific Enquiries Sherif Farouk Sherif.farouk@outlook.com 01099811994 10 abbas el akad street nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Professor of anesthesia ain shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial, after deidentification Study Protocol Following publication Any purpose
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