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.: PACTR202008864862556 Date of Approval: 20/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title erector spinae block versus serratus plane block in multiple fracture ribs
Official scientific title The effect of erector spinae block versus serratus plane block on pain scores and diaphragmatic excursion in multiple rib fractures. A prospective randomized trial
Brief summary describing the background and objectives of the trial Rib fractures as a result of blunt thoracic trauma are associated with significant morbidity and mortality, with patients frequently requiring admission to the intensive care unit,considerable attention has been paid to the use of ultrasound-guided fascial plane block techniques such as the erector spinae plane block and serratus anterior plane block as alternatives that provide excellent analgesia while being simpler and theoretically safer to perform The aim of the present study is to investigate the efficacy of ultra-sound guided erector spinae block and serratus plane block on pain scores
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 21/07/2020
Actual trial start date
Anticipated date of last follow up 30/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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
Experimental Group erector spinae plane block Group I once once The ultrasound transducer will be applied in a longitudinal orientation about lateral to the spinous processes, allowing for visualization of adjacent transverse processes (TP). After correct TP identification the needle is inserted using an in-plane approach to contact the bony shadow of the TP and injection of 20 ml bupivacaine 0.25% with dexamethasone 4 mg will be done 25
Control Group serratus plane block once once the serratus muscles will be identifiable by ultrasound overlying the fifth rib the needle is inserted using an in-plane approach. The anesthetic solution 20 ml bupivacaine 0.25% with dexamethasone 4 mg will be injected between latissimus dorsi and serratus anterior at the 5th rib level in the mid axillary line 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients, of both sexes aged 18-60 years old, classified by the American society of anesthesiologists as ASA I and II Patients refusal coagulation disorders body mass index ≥35 spine or chest wall deformity chronic analgesic use known allergy to study drugs uncooperative patients, patients with bilateral rib fractures will be excluded 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 01/06/2020 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El Geish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain score will be measured immediately before the blocks, then at 30 minutes, 2, 6, 12 and 24 hours after block
Secondary Outcome total analgesic requirement and diaphragmatic excursion total analgesic requirement once within 24 hour and Diaphragmatic excursion will be measured before and after the blocks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals El Geish Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Blough El Mourad El Geish tanta 31527 Egypt
Rehab Abd El fattah Mohamed Helal El Geish tanta 31527 Egypt
Dina Ahmed Ali El Malla El Geish tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina El Malla dina.elmalla@med.tanta.edu.eg 0020403317928 EL Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mona El Mourad monamorad80@gmail.com 0020403317928 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant Professor of Anesthesia Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Rehab Helal Rehabhelal2@gmail.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1- Demographic data age, sex , weight, height 2- pain score 3- Diaphragmatic excursion 4-patient satisfaction Study Protocol 2 years to those who request the data via the email of the= principal investigator according to the cause of 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