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.: PACTR202207703483624 Date of Approval: 18/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Serratus anterior plane block versus rhomboid intercostal and subserratus block for continuous analgesia in rib fractures
Official scientific title Serratus anterior plane block versus rhomboid intercostal and subserratus block for continuous analgesia in rib fractures
Brief summary describing the background and objectives of the trial Pain management is the cornerstone for treatment of rib fractures. Effective analgesia prevents hypoventilation, enables deep breathing, adequate coughing with clearance of pulmonary secretions, and compliance with chest physiotherapy. Overall, this reduces secondary pulmonary complications, including atelectasis, pneumonia, respiratory failure, and the need for respiratory support. Thoracic epidural analgesia has become the standard of care when opioid analgesia is inadequate but it may lead to hypotension in patients with unstable hemodynamics, concomitant thoracic spine injury, epidural hematoma, spinal cord injury so we use new blocks as Serratus anterior plane (SAP) block and The rhomboid intercostal and subserratus (RISS) block for analgesia of rib fractures.
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: Other
Anticipated trial start date 29/06/2022
Actual trial start date 29/07/2022
Anticipated date of last follow up 01/07/2023
Actual Last follow-up date 30/07/2023
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Not yet 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
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Serratus anterior plane block for continuous analgesia in rib fractures We will inject a bolus of 0.3 mL/kg (1.5 mg/kg) bupivacaine 0.5%. Then we will insert a catheter 2-3 cm into the space, tunnel, and secure in place. Correct catheter placement will be confirmed by demonstrating further bupivacaine spread under ultrasound visualization. Bupivacaine 0.25% will be infused (weight dependant) at 0.1 mL/kg/h via an elastomeric pump. it will be kept running for up to 7 days if no signs of infection and we will ensure not to exceed maximum dose. The patient will be in the supine position with abducted arm. A high frequency linear ultrasound probe set between 6 and 13 MHz will be used. The probe will be placed in the sagittal plane and identify the fifth rib in the mid-axillary line. Latissimus dorsi and serratus anterior muscles will be easily identifiable overlying the fifth rib. The planes will be found between a depth of 1-2 cm from the skin, with the thoracodorsal artery passing in the superficial plane to serratus anterior. After sterilization and local anaesthetic infiltration, an 18 Gauge Tuohy catheter needle will be used. The needle will be inserted in plane superficial to the serratus anterior muscle. Bupivacaine will be injected and good spread between latissimus dorsi and the serratus muscle will be confirmed. We will ensure not to exceed the maximum local dose of bupivacaine. We will inject a bolus of 0.3 mL/kg (1.5 mg/kg) bupivacaine 0.5%. Then we will insert a catheter 2-3 cm into the space, tunnel, and secure in place. Correct catheter placement will be confirmed by demonstrating further bupivacaine spread under ultrasound visualization. Bupivacaine 0.25% will be infused (weight dependant) at 0.1 mL/kg/h via an elastomeric pump and it will be kept running for up to 7 days if no signs of infection and we will ensure not to exceed maximum dose. 25 Active-Treatment of Control Group
Experimental Group Rhomboid intercostal and subserratus block for continuous analgesia in rib fractures A bolus of 0.15 mL/kg bupivacaine 0.5% will be injected in the fascial plane between the rhomboid major muscle and the intercostal muscles and 0.15 mL/kg bupivacaine 0.5% will be injected in the tissue plane between the serratus anterior and external intercostal muscle, hydrodissecting the tissue plane between the serratus anterior muscle and the attachments of the serratus to the rib then bupivacaine 0.25% will be infused (weight dependant) at 0.1 mL/kg/h via an elastomeric pump. It will be kept running for up to 7 days if no signs of infection and we will ensure not to exceed maximum dose. The patient will be placed in the sitting position with abducted and internally rotated arm to move the inferior angle of the scapula laterally. A linear ultrasound transducer (6-13 MHz) will be placed in the sagittal plane medial to the medial border of the scapula with the orientation marker directed cranially. The transducer will be then rotated so the cranial end will be directed slightly medially and the caudal end laterally to produce an oblique sagittal view (paramedian sagittal oblique) approximately 1 to 2 cm medial to the medial scapular border. The following structures will be identified from superficial to deep: trapezius muscle, rhomboid major muscle, intercostal muscles between ribs, pleura, and lung. The tissue plane between the rhomboid major and intercostal muscles will be identified. An18 Gauge Tuohy needle will be advanced in plane from a supero-medial to infero-lateral direction, through the trapezius and rhomboid major muscles. 0.15 mL/kg bupivacaine 0.5% will be injected in the fascial plane between the rhomboid major muscle and the intercostal muscles. The skin entry point for the first injection will be at the T5-T6 level just medial to the scapula. Two landmarks verified identification of the T5-T6 level: 1. Counting down from the C7 spinous process 2. Identifying the medial part of the spine of the scapula at the T3 level. Next, to identify the subserratus plane, the transducer will be moved caudally and laterally, distal to the inferior angle of the scapula behind the posterior axillary line. Tissue layers will be identified from superficial to deep: latissimus dorsi, serratus anterior, intercostal muscles between ribs, pleura, and lung. The needle will be inserted at the same skin entry site as that will be used for the rhomboid intercostal injection but will be directed caudally and laterally beyond the inferior angle of the scapula. If the needle tip won’t reach beyond the inferior edge of the scapula (eg, obese and tall habitus), a new skin entry point medial to the lower angle of the scapula and posterior axillary line will be used. 0.15 mL/kg bupivacaine 0.5% will be injected in the tissue plane between the serratus anterior and external intercostal muscle, hydrodissecting the tissue plane between the serratus anterior muscle and the attachments of the serratus to the rib. We will ensure not to exceed the maximum bupivacaine dose. Then we will insert a catheter 2–3 cm into the space, tunnel, and secure in place. Correct catheter placement will be confirmed by demonstrating further bupivacaine spread under ultrasound visualization. Bupivacaine 0.25% will be infused (weight dependant) at 0.1 mL/kg/h via an elastomeric pump, and will be kept running for up to 7 days if no signs of infection and we will ensure not to exceed maximum dose. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients of both gender, aged between 18-60 years with isolated thoracic trauma leading to unilateral multiple rib fractures ≤ 6 ribs and admitted to trauma intensive care unit at Mansoura University Emergency Hospital. Patients with > 6 rib fractures, bilateral fractures, flail chest, intubated and sedated patient, associated intracranial hemorrhage which affects patient’s mental status, trachea, larynx and sternum fractures, polytrauma patients, hypersensitivity to bupivacaine, infection at the site of injection, bleeding disorders, hepatic, cardiac and renal failure and patients with body mass index >35. 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 07/04/2022 Medical Research Ethics committee Institutional Review Board Mansoura Faculty of medicine Mansoura university
Ethics Committee Address
Street address City Postal code Country
el gomhoria street , el mansoura el mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in pain intensity measured by visual analogue score (VAS) after 24 hour of bupivacaine infusion. after 24 hour of bupivacaine infusion
Secondary Outcome - Change in pain intensity measured by visual analogue score after 2 hour, 48 hour, 72 hour and every 24 hour till the catheter removed - Intensive care unit (ICU) length of stay (LOS). - Need for respiratory support (non-invasive or invasive mechanical ventilation). - Development of pneumonia or respiratory failure. - Development of complications of the block (pneumothorax, hemothorax and local anesthetic toxicity). - In-hospital mortality. - Total pethidine consumption. at 2 hours after bupivacaine injection and at 48 hour , 72 hour of bupivacaine infusion and every 24 hour till the catheter removed
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Trauma intensive care unit at Mansoura University Emergency Hospital el gomhoria street- el mansoura el mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
trauma intensive care unit at Mansoura University Emergency Hospital Elgohoria street El mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university emergency hospital elgomhoria street, elmansoura elmansoura 35511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Mohamed Ahmed Sultan elmansoura elmansoura 35511 Egypt
Dr. Eiad Ahmed Ramzy elmansoura elmansoura 35511 Egypt
Dr. Marwa Ibrahim Abdo elmansoura elmansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Sultan dr.sultanicu1947@gmail.com 0020162839014 elmansoura
City Postal code Country Position/Affiliation
elmansoura 35511 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Eiad Ramzy eiad.ramzy@gmail.com 00201005774079 elmansoura
City Postal code Country Position/Affiliation
elmansoura 35511 Egypt professor
Role Name Email Phone Street address
Public Enquiries Marwa Abdo marwabdo@gmail.com 00201002477789 elmansoura
City Postal code Country Position/Affiliation
elmansoura 35511 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes “Data obtained through this study may be provided to qualified researchers with academic interest in anesthesia and ICU. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Statistical Analysis Plan,Study Protocol “Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.” “Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)''
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