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.: PACTR201306000535141 Date of Approval: 24/04/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Real-time ultrasound-guided transverse interlaminar Lumbar epidural access using an in- plane technique
Official scientific title Real-time ultrasound-guided transverse interlaminar Lumbar epidural access using an in- plane technique
Brief summary describing the background and objectives of the trial Till recently, the surface anatomical landmarks and ¿loss-of-resistance¿ (LOR) to saline or air was the golden standard to reach the lumbar epidural space. Therefore, any alternative technique that can facilitate localization of the epidural space is desirable. The aim of this study was to evaluate the feasibility of performing real-time U/S-guided midline lumbar epidural access, with the epidural needle inserted in a midline in- plane of the U/S beam, in a transverse interlaminar view.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,ultrasound guided lumbar epidural access
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 24/04/2013
Actual trial start date
Anticipated date of last follow up 24/06/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book. Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrasound guidance tranverse midline interspinous view using inplane technique 20
Control Group conventional surface landmark epidural access surface landmark lumbar epidural approach 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-III patients, age 20-60 years Patients were excluded if they had a BMI >35, clinically obvious or known spinal deformity, infection in the back, allergy to local anaesthetic drugs, previous spine surgery, morbid obesity or coagulopathy. 20 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 18/04/2013 Ethical committee of the Medical Research Institute
Ethics Committee Address
Street address City Postal code Country
165 Horreya road Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome easy access to epidural space using ultrasound guidance -visibility of neuraxial structures, using 4 point score for group I -Number of needle attempts depth between skin and dura -Sensory assessment was carried out by a lack of response to pinprick at the level of the umbilicus (T10), was performed every 5 minutes after the initial epidural injection -complications observed
Secondary Outcome earlier onset of the block, less complication rate, less dural punctures checking sensory level to T10 every 5 minutes in each patient
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Institute 165 Horreya road- Alhadara Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Institute 165 Horreya road- Alhadara Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Medical Research Institute 165 horreya road- elhadara- Alexandria 21561 Egypt Hospital
Primary Sponsor authors involved 165 Horreya road- Alhadara Alexandria 21561 Egypt Hospital
Primary Sponsor Sherif A .Abdelhamid 165 horreya road- elhadara- Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
authors involved 165 Horreya road- Alhadara Alexandria 21561 Egypt
Sherif A .Abdelhamid 165 horreya road- elhadara- Alexandria 21561 Egypt
Ahmed Zidan 165 horreya road- elhadara- Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Abdelhamid dr_shereif@hotmail.com 00201001459756 165 horreya road
City Postal code Country Position/Affiliation
alexandria 21561 Egypt Lecturer of anaesthesia
Role Name Email Phone Street address
Public Enquiries sherif Abdelhamid dr_shereif@hotmail.com 002034284659 165 horreya road
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anaesthesia
Role Name Email Phone Street address
Scientific Enquiries Ahmed Zidan luckyhamada@yahoo.com 002034284659 165 horreya road
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anaesthesia
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information