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.: PACTR201911762148834 Date of Approval: 25/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of subomohyoid plane block and interscalene nerve block for Arthroscopic shoulder surgery
Official scientific title Comparison of subomohyoid plane block and interscalene nerve block for Arthroscopic shoulder surgery
Brief summary describing the background and objectives of the trial Shoulder arthroscopy is associated with moderate to severe postoperative pain (1). Interscalene brachial plexus block (ISBPP) is widely used for postoperative pain management after shoulder surgery however, it is associated with many adverse sequels resulting from unexpected spread of local anesthetics to the phrenic nerve, the sympathetic ganglia and other nervous tissues, resulting in transient ipsilateral hemi diaphragmatic paresis ,Horner’s syndrome and hoarseness (2).phrenic nerve palsy may lead to serious pulmonary complications in respiratory high risk patients (3).the suprascapular nerve providing 70% of the sensory innervation to the glenohumeral joint and also innervates the infraspinatus and supraspinatus muscle(4).The suprascapular nerve block (SSNB) has been proposed to provide sufficient analgesia for shoulder surgery with less incidence of phrenic palsy in comparison to (ISBPP) and has consequently been suggested as an (ISBPP) alternative (5).Recently, Seigenthaler et al have described a proximal ultrasound guided selective anterior suprascapular nerve block within the supraclavicular fossa as the posterior approach to the suprascapular nerve has inferior analgesic efficacy and high failure rate (6). For the subomohyoid plane block, high frequency ultrasound probe is placed over the supraclavicular fossa to identify the subclavian artery, brachial plexus and the inferior belly of the omohyoid muscle. Local anesthetics are then deposited above the clavicle, under the inferior belly of omohyoid to cover the suprascapular nerve. This fascial plane between the inferior belly of omohyoid and the strap muscles of the neck is closely related to the suprascapular nerve along its course until the suprascapular notch (7). The subomohyoid plane block is a new technically easy and reliable regional anesthetic technique that can be used for pain management, it is not extensively examined as regards efficacy and safety in comparison to the standard (ISBPB).
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 regional anesthesia techniques
Anticipated trial start date 15/11/2019
Actual trial start date
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group interscalene brachial plexus nerve block. during surgery and during the first 24 h postoperatively All patients will receive an ultrasound guided nerve block that will be done by an experienced anesthesiologist. using Linear probe (5-12 MHz),hypoechoic nerve roots or the superior trunk located between the anterior and middle scalene muscles will be identified and after sterile skin preparation, the point where C5,C6 and C7 roots or superior trunk were most visible, will be selected. The tip of the needle will be advanced towards C5 and C6 roots or superior trunk within the sheath using the in-plane method. Then after successful needle placement, patients will receive 15 ml 0.5% bupivacaine. 30 Active-Treatment of Control Group
Experimental Group subomohyoid plane block during surgery and during the first 24 h postoperative All patients will receive an ultrasound guided nerve block that will be done by an experienced anesthesiologist. For the sub-omohyoid block, high frequency (5-15 MHz) ultrasound probe will be used. using an in-plane lateral to medial needle approach, 15 ml 0.5% bupivacaine will be deposited above the clavicle, under the inferior belly of omohyoid, to cover the suprascapular nerve. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 18 and 70 years, American society of anesthesiologists (ASA) physical status I to II and body mass index <35. Exclusion criteria of the patients: coagulation deficiencies, known allergy to local anesthetics, neurological deficits on the side of the operation, inflammation at the brachial plexus puncture side, respiratory insufficiency, contralateral hemi diaphragmatic paralysis, pneumonectomy or vocal cord palsy, diabetes mellitus, and psychiatric disorders. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 24/10/2019 Ethics committee Faculty of medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
7 Champollion Street, El Messalah, Alexandria, Egypt. Alexandria 21568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcomes will include pain severity at rest using visual analog scale (VAS) at PACU 2,4,6,12,18 and 24 h postoperatively. Pain will be assessed at rest only because the surgeons restrained the active movement of the operated shoulder. Time (in min) from the end of local anesthetics administration to the first rescue analgesic request (i.e. intravenous morphine bolus) which correspond to VAS >4. The number of patients who requested IV bolus morphine, overall morphine consumption in the first postoperative day. Number of patients satisfied or unsatisfied from analgesia at the end of postoperative day. 2,4,6,12,18 and 24 h postoperatively
Secondary Outcome Evaluation of postoperative respiratory function; a chest radiograph will be done for all patients during the postoperative period and incidence of oxygen desaturation, pneumothorax, dyspnea and phrenic nerve palsy will be recorded during the first postoperative day. Opioid related side effects; (postoperative nausea and vomiting respiratory depression, pruritus and sedation) during the first postoperative day. Undesirable blockade of nerves or anatomical areas not involved in the surgery (cervical plexus, recurrent laryngeal nerve or forearm and hand) and block related complication (persistent paraesthesia, weakness and tingling) at the end of first postoperative day. first postoperative 24 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ElHadara university hospital EL Mostashfa EL Italy St. EL HADARA Qism Bab Sharqi, Alexandria Governorate, Egypt alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tarek Ismail 152 tiba st. sporting alexandria 21617 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tarek Ismail 152 tiba st. sporting alexandria 21617 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Rabab S. Mahrous EL Mostashfa EL Italy St. EL HADARA Qism Bab Sharqi, Alexandria Governorate, Egypt alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator TAREK ISMAIL SABRY MOHAMED ISMAIL drtarek.anesth@gmail.com 01001467166 152 tiba st. sporting
City Postal code Country Position/Affiliation
alexandria 21617 Egypt lecturer of anesthesia and intensive care helwan university egypt
Role Name Email Phone Street address
Public Enquiries Hanan Mina hananminaped@gmail.com 00201203032096 Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan
City Postal code Country Position/Affiliation
Helwan Egypt Lecturer of pediatrics Faculty of medicin Helwan university Cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries Tarek salem tareksalem00@gmail.com 00201112277417 Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan
City Postal code Country Position/Affiliation
cairo Egypt Vice Dean of Graduat Studies and Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Patients data after data entry in excel sheets Statistical Analysis Plan,Study Protocol additional documents will be available within 12 months after completion of the study. open access to IPD to reviewers. Data will be send directly by email upon request.
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