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.: PACTR202301909806348 Date of Approval: 19/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultra Sound guided Erector Spinae Plane (ESP) block versus Intravenous Opioids Based Analgesia in Patients with Rib Fractures
Official scientific title Ultra Sound guided Erector Spinae Plane (ESP) block versus Intravenous Opioids Based Analgesia in Patients with Rib Fractures
Brief summary describing the background and objectives of the trial Rib fractures are the most common thoracic blunt trauma injury. They are a common cause of hospital admission and are associated with significant morbidity and mortality. The key element to prevent post-fracture complications is optimal analgesia. There has been growing interest in the Erector Spinae Plane (ESP) block for the management of rib fractures. The ESP block has been reported to provide effective analgesia with minimal complications, however its efficacy compared to other analgesic options is poorly understood. This study aims to compare the effect of the ESP block and opioid based analgesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied analgesia in patients with rib fractures
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 13/06/2021
Actual trial start date 05/07/2021
Anticipated date of last follow up 15/05/2022
Actual Last follow-up date 02/06/2022
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Erector Spinae plane block follow up for 12 hours after the block Ultra sound guided Erector Spinae plane block was given, 20ml of bupivacaine 0.25% was injected pain was assessed by VAS score at rest anf after spirometer exercise before block and 30 min, 6h and 12h after the block peak inspiratory flow rate was assessed by incentive spirometer 26
Control Group intravenous Morphine follow up for 12 hours Patients in this group received intravenous Morphine 0.1mg/kg then they were provided with intravenous patient controlled analgesia (PCA) device of 100 ml volume containing morphine 40 mg and normal saline at a rate of 2ml/h 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients aged between 21 – 60 years old. • Both sexes. • ASA 1 or 2 Patients. • Patients presented with unilateral multiple consecutive rib fractures (3 or more) and admitted to ICU. • Refusal of the intervention or participation in the study. • Unable to communicate effectively. • Sternal fractures or bilateral rib fractures. • Bleeding disorders. • Relevant drug allergy. - significant lung or pleural injuries. • Significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries. • Intubated patients. • Local infection at the site of intervention. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 20/06/2021 Ain shams university faculty of medicine research ethics committee
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine Ain Shams university, Abbasia cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain assessment which was done using 10 cm VAS score at rest and after spirometer exercise , peak inspiratory flow rate as measured by incentive spirometery before intervention, 30min, 6h and 12h after intervention
Secondary Outcome rescue morphine requirements in 12 hours, Any complications during or after the intervention were recorded. during intervention and for 12 h after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals 56th Ramses street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Soha Elmansy 96th villa, Elnarges 5, 5th settlement, New cairo Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor soha elmansy 96th villa, Elnarges 5, 5th settelement cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Soha Elmansy soha.elmansy@hotmail.com +201092446364 96th villa, Elnarges 5, 5th settelment, newcairo
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Mohammed Abdelkhalek mohd_khalik@hotmail.com +201001474755 Abassia
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Sherif Farouk sherifibrahim210@yahoo.com +201099811994 Abassia
City Postal code Country Position/Affiliation
cairo Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data that will be shared is the individual participants data that underlie the results reported in this article after de-identification ( texts, tables and figures) Informed Consent Form,Study Protocol beginning 12 months after article publication to 24 months after publication 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 all applicable agreements (i.e. material transfer agreements)
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