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.: PACTR202202483221034 Date of Approval: 16/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound Assessment of Diaphragmatic Movement Post Selective Superior Trunk Block versus Conventional Interscalene Block in Shoulder Arthroscopy
Official scientific title Ultrasound Assessment of Diaphragmatic Movement Post Selective Superior Trunk Block versus Conventional Interscalene Block in Shoulder Arthroscopy
Brief summary describing the background and objectives of the trial Shoulder surgery is one of the most common ambulatory orthopedic procedures, with more than 500,000 estimated cases performed each year in the United States alone. Advances in arthroscopic techniques have resulted in decreased recovery times and complication rates . However, postoperative analgesia continues to pose a major challenge, with 20% of patients reporting maximum pain scores on the first postoperative day after being discharged home. (1) Symptoms have been effectively managed with interscalene block (ISB). But its benefits have usually been offset by high rates of hemi diaphragmatic paralysis (HDP) via unintentional phrenic nerve blockade . (2) This side effect may not be a problem to healthy patients, but it can be very critical in patients with pre-existing pulmonary pathology.(3) The superior trunk block was described by Burckett-St. Laurent et al. as a refinement of the conventional interscalene block technique. The superior trunk is formed by the fusion of C5and C6 nerve roots, and therefore local anesthetic injection around the superior trunk should produce similar analgesia of the shoulder because all the terminal nerves innervating the shoulder arise distal to the superior trunk. Moreover, the site of injection is further away from the phrenic nerve, and this should theoretically reduce the risk of hemi diaphragmatic paralysis. (4) Therefore‚ we will design the present randomized, clinical trial to investigate whether the superior trunk block will reduce hemi diaphragmatic paresis in patients undergoing arthroscopic shoulder surgery or not.
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: Surgery
Anticipated trial start date 13/02/2022
Actual trial start date
Anticipated date of last follow up 01/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants)
Recruitment status Completed
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group the interscalene block group 24 hour the US transducer will be applied in sterile fashion on the supraclavicular fossa to find the brachial plexus division lateral to the subclavian artery. Then, the transducer will be traced cephalad to find it in the interscalene groove at the level of the cricoid cartilage. The plexus will typically be seen as multiple anechoic circular structures with a "stoplight" appearance. Typically, the topmost structure is C5, while the middle and lower structures are both C6 as it divides. The block needle will be inserted in-plane from posterior to anterior and lateral to medial toward the interscalene groove. At this point, one-half dose of the LA will be injected slowly. The needle will be withdrawn 1–1.5cm and will be re-advanced laterally between the upper C5 root and the prevertebral fascia. The remaining one-half dose of LA will be then injected slowly. 34 Active-Treatment of Control Group
Experimental Group the superior trunk block group 24 hour after finding the needling position in the same way as above, the transducer will be moved distally until the superior trunk will be first seen. The needle will be advanced to the anterior part of the superior trunk, and one-half dose of LA will be injected. The needle will be withdrawn 1–1.5 cm and re-advanced to the posterior part of the superior trunk, and the remaining one-half dose of LA will be injected. 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sixty eight patients scheduled for arthroscopic shoulder surgery of both sex aged 18 to 80 years with American Society of Anesthesiologists (ASA) physical status I or II will be enrolled in the study. Exclusion criteria include pre-existing neuropathy in the operated limb, ASA ≥ III, coagulation disorders, known allergy to local anesthetics, local infection at the puncture site, chronic obstructive pulmonary disease or respiratory failure, pregnancy, breast-feeding, BMI ≥ 35 kg/m2, failure to cooperate, and refusal to participate. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 22/01/2022 anesthesia and intensive care department
Ethics Committee Address
Street address City Postal code Country
25- yassen abdel ghafar shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of diaphragmatic movement affection by ultrasound guidance . after block injection
Secondary Outcome The quality of sensory and motor blocks, time for the first call of analgesia , intraoperative hemodynamic parameters, intraoperative fentanyl consumption and complications of either blocks. 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofia university hospital 25- yassen abdel ghafar shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
noha afify 25- yassen abdei ghaffar shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine . menofia university 25- yassen abdel ghafar shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all IPD will be collected and statistically analysed and tubulated Study Protocol unpredictable unavailable
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