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.: PACTR202009808496646 Date of Approval: 23/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study Between Infraclavicular Sub-omohyoid Block (Iso Block) And Interscalene Block During Shoulder Surgery Under General Anesthesia
Official scientific title Comparative Study Between Infraclavicular Sub-omohyoid Block (Iso Block) And Interscalene Block During Shoulder Surgery Under General Anesthesia
Brief summary describing the background and objectives of the trial Interscalene nerve block (ISB) are the pain relief standard for shoulder surgery. But ISB is invasive and associated with complications. Infraclavicular Sub-omohyoid block (ISO block) may be an alternative; but evidence of comparative efficacy is sparse. This study aimed to examine whether ISO block is non-inferior to IS block for pain after shoulder surgery.
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 25/05/2020
Actual trial start date 09/06/2020
Anticipated date of last follow up 15/09/2020
Actual Last follow-up date 10/10/2020
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group ISO 25 to 30 ml of local anesthesia was injected after induction of general anesthesia for about 3 h was performed and confirmed with ultrasound (GE® LOGIQ P5 digital ultrasound system, china The needle is inserted 2-3 cm superior to the clavicle and advanced (using an in-plane technique) posterior to the clavicle, towards the cords, and local anesthetic 25-30 ml is injected. To block the suprascapular nerve (sub-omohyoid technique), the linear probe is repositioned between the needle and the clavicle and adjusted to identify the inferior belly of omohyoid longitudinally. The needle tip is the redirected (using the out-of-plane technique) towards the interfacial plane deep to the omohyoid between the omohyoid and subscapularis/serratus anterior muscles), where local anesthetic 5ml is injected. This injection is more lateral than the previously described to minimize medial spread. 30 Active-Treatment of Control Group
Experimental Group GroupI ISC 25 to 30 ml of local anesthesia was injected after induction of general anesthesia for about 3 h The needle is then inserted in-plane toward the brachial plexus, typically in a lateral-to-medial direction, although medial-to­ lateral needle orientation can be also chosen if more convenient. After a careful aspiration to rule out an intravascular needle placement, 1 to 2 ml of local anesthetic is injected to document proper needle placement. Injection of several millimeters of local anesthetic often displaces the brachial plexus away from the needle. Injection of 25 to 30 ml is adequate when visualization of the brachial plexus between the scalene muscles proves difficult; the transducer is lowered to the supraclavicular fossa. At this position, the brachial plexus is identified lateral and superficial to the subclavian artery. From here, the brachial plexus is traced cranially to the desired level (the traffic light appearance between the anterior and middle scalene muscles). 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age from 18 to 65 years , ASA physical status: I, II and III and Type of operations : Patients undergoing shoulder surgery Patients with BMI < 18.5 or >30 kg/m2, Patients with coagulation disorders, Local skin infection at the site of injection , Patients with known allergy to one of the used drugs. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 07/06/2020 Benha Unlvaslty Faculty of Medlclne Research Ethlcs Commltbc.
Ethics Committee Address
Street address City Postal code Country
Farid nada st.Benha Benha 13511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome decrease of VAS score and decrease og analgesic requirement and decrease of complication aspneumothorax,ipsilateral phrenic nerve block 7 times
Secondary Outcome significantly less frequent phrenic nerve block and overall complications and with slightly difference in postoperative analgesia. Therefore, it may be relevant to consider for patients who cannot tolerate a phrenic nerve block. 7 times
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha university hospital Farid nada st.Benha Benha 13511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha university hospital Farid nada st Benha 13512 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha university hospital Farid nada se,Benha Benha 13511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
anaethesia and orthopedic collaborator farid nada st. Benha 13511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ENAS MAHDY ewm01221592827@gmail.com 00201029286117 47 EL-moetasem st
City Postal code Country Position/Affiliation
Benha 13511 Egypt leccture of anesthsia
Role Name Email Phone Street address
Principal Investigator AHMED ABD ELREHMAN ahmed76hamdy@yahoo.com 00201004337483 Mit Asem-Benha Qlluobia
City Postal code Country Position/Affiliation
Benha 13814 Egypt leccture of anesthsia
Role Name Email Phone Street address
Scientific Enquiries AHMED Abd ELHamid bashaahmed@yahoo.com 00201005204130 20 Ezz ELdin omar st.ELharam
City Postal code Country Position/Affiliation
Giza 12111 Egypt professor of anesthesia
Role Name Email Phone Street address
Public Enquiries Saad Saad saaddibrahim-7@yahoo.com 00201223142889 Oman st.Elmohandseen,Giza
City Postal code Country Position/Affiliation
Giza 12111 Egypt professor of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual data are available ,individual participant data that underlie the results reported in this article after de identification (text,tables.figures)other documents will be available like study protocol. the data will be available immediately following publication.No time detected with investigator whose proposed use of the data has been approved by an independent reviewer committe 2 months it is controlled request type ,type of data analysis is predictive ,proposal should be directed to enaswageh@yahoo.com.to gain access,data requestor will need to sign a data access agreement.data will be available for 5 years at third party website (www.bu.edu.eg)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.bu.edu.eg Yes 21/08/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information