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.: PACTR202012481127081 Date of Approval: 11/12/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The transverse skin creases crossing the lumbar interspinous spaces can guide spinal anesthesia in obese patients
Official scientific title The transverse skin creases crossing the lumbar interspinous spaces can guide spinal anesthesia in obese patients
Brief summary describing the background and objectives of the trial Identifying the midline in obese patients during central neuraxial blockade can be challenging. Recently, the use of ultrasound imaging has become more popular in identifying vertebral structures at high resolution and locating an accurate needle insertion point during regional anesthesia. A simple sign had been observed in obese patients which is the lumbar transverse skin creases which are so evident in these categories of patients. The lumbar transverse creases were used as a guide to the interspinous spaces. The aim of the work is to compare the use of ultrasound versus lumbar transverse skin crease in the identification of the interspinous space in obese patients.
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 Diagnosis / Prognosis
Anticipated trial start date 01/01/2021
Actual trial start date
Anticipated date of last follow up 31/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transverse skin crease group Once Use the anatomical lumbar transverse crease in obese patients as a guide to interspinous space 150
Control Group Lumbar ultrasound group Once Use of the low-frequency curvilinear probe on the lumbar vertebrae to identify the spines and the interspinous space 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients ASA I,II scheduled for surgeries that will be done under spinal anesthesia BMI > 30 Those who will refuse participation in the study. Surgeries done under GA. Contraindication to spinal anesthesia; infection or bleeding tendency. Patients with known or evident spinal deformity (Scoliosis) Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 15/10/2020 Ethics Committee Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 champlion street elmessalah Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time taken from the start of ultrasound or lumbar crease till we get CSF flow Time from we put the probe on the back or identifying the lumbar crease till the CSF is got
Primary Outcome Number of attempts till we get CSF flow throughout the procedure
Secondary Outcome spinal deformities which make the identification of the interspinous space difficult Once at the time of the ultrasound to detect sonoanatomy of the back
Primary Outcome Number of patients with CSF flow from first attempt skin puncture Start of the procedure
Secondary Outcome Number of redirection of spinal needle till CSF flow Start of the procedure
Secondary Outcome Number of patients with deviated spines from the midline Start of the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Sidney Keil hospital Private obstetric hospital 16 Abdelhamid elabadi st. roushdy Alexandria Alexandria 21529 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Wessam alamrawy 1 mostafa kamel street Montaza Alexandria 21637 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesiology and Surgical Intensive Care Faculty of Medicine Alexandria University 17 champlion street elmessalah Alexandria 21131 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed elattar 47 sultan Hussein st. flat 203 azarita Alexandria 21521 Egypt
Wessam alamrawy 1 mostafa kamel street Alexandria Egypt montaza Alexandria 21637 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elattar Ahmed.alattar@alexmed.edu.eg 01222144835 47 sultan Hussein st. flat 203 azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anesthesiology and Surgical Intensive Care Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Wessam Alamrawy Wesam_amrawy@yahoo.com 00201280998606 1 mostafa kamel street Alexandria Egypt montaza
City Postal code Country Position/Affiliation
Alexandria 21637 Egypt Lecturer of anaesthesia and pain management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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