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.: PACTR202008748292105 Date of Approval: 25/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety of regional analgesia for postoperative pain management in shoulder arthroscopy
Official scientific title Respiratory and analgesic effects of ultrasound guided subomohyoid suprascapular nerve block versus interscalene brachial plexus block in shoulder arthroscopy.
Brief summary describing the background and objectives of the trial Opioid-only analgesic techniques for shoulder surgery are commonly associated with opioid-related adverse effects Multi-modal analgesic approaches incorporating paracetamol, non-steroidal anti-inflammatory drugs and tramadol can reduce opioid requirements; however, opioid consumption remains significant Patients can be rendered pain-free with the use of a single-shot interscalene brachial plexus block While some potential side effects from ISB, such as phrenic nerve block, recurrent laryngeal nerve involvement and Horner’s syndrome, may lead to patient discomfort, others, such as neurological injury, intrathecal spread and systemic toxicity of local anesthetic can have serious consequences Performing an anterior suprascapular nerve block under the inferior belly of the omohyoid muscle in the supraclavicular fossa seems to consistently block the superior trunk and brachial plexus, even when very small local anesthetic volumes are used. Consequently, we thought that the subomohyoid anterior suprascapular block is another approach to superior trunk block that blocks the majority of shoulder innervation, thus providing postoperative analgesia that is not worse than the interscalene block for shoulder surgery The aim of this study is to evaluate the preservation of diaphragmatic function with subomohyoid suprascapular nerve block as a method of shoulder analgesia in comparison with interscalene brachial plexus block in patients undergoing arthroscopic shoulder surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial acute pain management
Anticipated trial start date 15/08/2020
Actual trial start date
Anticipated date of last follow up 15/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 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 interscalene brachial plexus block 15 ml of 0.25% bupivacaine will be injected single shot injection preoperative Patients in group I will be placed in the supine position with the neck rotated to the contralateral side. The ultrasound probe will be placed in a transverse orientation at the level of the 6th cervical vertebra to locate the anterior and middle scalene muscles with the trunks of brachial plexus inbetween. The tip of the needle will be advanced in an in-plane position between the three trunks of the brachial plexus. The correct position will be confirmed by observing the perineural spread of 1 - 2 ml of the injected local anesthetic (LA) solution, followed by a further slow injection of the rest of LA. In addition, patients will receive an ipsilateral sham suprascapular block. 30 Active-Treatment of Control Group
Experimental Group subomohyoid suprascapular nerve block 15 ml of 0.25% bupivacaine will be injected single shot injection will be done preoperative The ultrasound transducer will be placed in the transverse plane in the supraclavicular fossa to visualize the superior trunk in the short axis. The suprascapular nerve will be identified as it branched off from the superior trunk and will be traced until it coursed beneath the inferior belly of the omohyoid muscle. The needle will be inserted in line with the probe in a lateral-to-medial orientation toward the suprascapular nerve. Local anesthetic solution will be injected in 5-ml aliquots after negative aspiration for blood to achieve circumferential spread around the neurovascular bundle. Patients also will receive a sham interscalene block. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged 18-60 years both gender classified by the American Society of Anesthesiologists as ASA I-II scheduled for elective arthroscopic shoulder surgery patient's refusal pre-existing obstructive or restrictive pulmonary disease pre-existing neurological disease or psychiatric disorders neuropathy or myopathy of the surgical limb infection at site of the block allergy to local anesthetics body mass index >35 kg/m2 chronic analgesic use inability to express NRS score 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 27/07/2020 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Elgeish St Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of reduction in diaphragmatic excursion using ultrasound assessment baseline before the block then after the block
Secondary Outcome Pulmonary function tests (FEV1, FVC, and PEF) baseline before the block, then after the block
Secondary Outcome pain score. Pain will be evaluated using NRS on arrival to PACU, at 1, 2 h postoperative then at 6, 12, and 24 hours postoperative.
Secondary Outcome Time to first postoperative analgesic request postoperative
Secondary Outcome Total opioid consumption in first 24 hours postoperative
Secondary Outcome Incidence of adverse events in first 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Facualty of Medicine Elgeish St Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mona Raafat Elghamry Elgeish St Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mona Raafat Elghamry Elgeish St Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohammad Ali Abduallah Elgeish St Tanta 31527 Egypt
Mona Blough ElMourad Fayad Elgeish St Tanta 31527 Egypt
Mona Raafat Elghamry Elgeish St Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad Abduallah Moh_aly_2005@hotmail.com +201099957971 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Mona Fayad monamorad80@gmail.com +201019425213 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Mona Elghamry drmonagh19802000@gmail.com +201060101867 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of incidence of reduction in diaphragmatic excursion, pain score,duration of analgesia,total 24 h postoperative opioid consumption,adverse events Statistical Analysis Plan IPD will be shared after finishing and publication of the study and it will be available for 6 months the IPD will be available for scientific research only up on e-mail request. request will be sent to e-mail of one of the authors (drmonagh19802000@gmail.com)
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