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.: PACTR201812794533961 Date of Approval: 12/12/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Infraclavicular–SubOmohyoid (ISO) block versus interscalene brachial plexus block
Official scientific title Infraclavicular–SubOmohyoid (ISO) block versus interscalene brachial plexus block; diaphragmatic excursion and perioperative analgesia: a prospective randomized trial
Brief summary describing the background and objectives of the trial Shoulder surgery typically results in moderate to severe postoperative pain, especially within the first 24 h after surgery. [1] The interscalene block is one of the most effective analgesic techniques for shoulder surgery. Compared with other techniques, it provides superior analgesia and reduced opioid-related adverse effects. [2] However, it may be associated with a 100% incidence of ipsilateral hemidiaphragmatic paresis, resulting from a phrenic nerve block. [3,4] This side effect potentially undermines the benefit of regional anesthesia for patients suffering from moderate to severe respiratory dysfunction. [5-7] In addition, the interscalene block is associated with a higher risk of transient neurological symptoms than other peripheral nerve blocks. [8] To bypass this complication, distal block of the shoulder innervation is recommended. [9] Blocking the axillary nerve and suprascapular nerve can provide adequate analgesia for minor shoulder surgery, but for major surgery both infraclavicular and suprascapular nerve blocks are required. [9] To minimize block time and patient discomfort, both infraclavicular and suprascapular nerve blocks can be performed with a single-puncture technique (the ISO block). The ISO block anaesthetizes the entire innervation of the shoulder joint and muscles. By adding skin infiltration at incision, a totally opioid-free anesthetic can be achieved. The aim of this prospective randomized trial is to compare the effects of ISO block versus interscalene block on diaphragmatic excursion as a primary outcome and analgesia and pulmonary function as secondary outcomes in patients undergoing shoulder surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,perioperative analgesia for shoulder surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/12/2018
Actual trial start date 20/01/2019
Anticipated date of last follow up 15/06/2019
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
32652 Tanta University Faculty of Medicine Research Ethics Committee Quality Assurance Unit
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group interscalene brachial plexus block 20 ml bupivacaine 0.25% single shot interscalene brachial plexus block 30 Active-Treatment of Control Group
Experimental Group Infraclavicular SubOmohyoid block infraclavicular block (posterior technique) using 25 ml bupivacaine 0.25% plus suprascapular nerve block (subomohyoid technique) using 5ml bupivacaine 0.25% single shot ISO block composed of infraclavicular block (posterior technique) plus suprascapular nerve block (subomohyoid technique) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged 18 – 60 years of either gender ASA I-II undergoing elective shoulder surgery patient refusal, patients with severe respiratory disease pre-existing neurological, psychiatric or neuromuscular diseases coagulopathy renal or hepatic diseases allergy to study drugs morbid obesity. Adolescent: 13 Year-18 Year,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 01/10/2018 Tanta University Faculty of Medicine Research Ethics Committee Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
Algeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The rate of diaphragmatic hemiparesis 30 min after the block procedure
Secondary Outcome duration of postoperative analgesia once at the time of 1st rescue analgesic request
Secondary Outcome postoperative pain score at PACU admission, 2h, 4h, 6h, 8 h, 12 h and at 24 h postoperatively
Secondary Outcome rate of pulmonary function 30 min after the block
Secondary Outcome total consumption of rescue analgesia at 24 h postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Faculty of Medicine Algeish street Tanta Egypt University
Secondary Sponsor Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mohye Eldin Mohd-yazed75@yahoo.com +201099707168 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt Assistant professor of anesthesia and surgical ICU Tanta University Faculty Of Medicine
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com +201270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and surgical ICU Tanta University Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin Mohd-yazed75@yahoo.com +201099707168 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt Assistant professor of anesthesia and surgical ICU Tanta University Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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