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.: PACTR201502000883351 Date of Approval: 08/09/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ultrasound guided femoral nerve block: needle versus needle technique
Official scientific title ultrasound guided femoral nerve block: needle versus needle technique
Brief summary describing the background and objectives of the trial ultrasound guided femoral nerve block is done using nerve stimulator needle to guarantee optimum local anesthetic deposition round the nerve in real time manner. the chance to change the nerve stimulator needle to a tuohy needle of an epidural set would be a much cheaper way in well trained ultrasound hands.our aim is to compare the epidural tuohy needle versus the nerve stimulator needle ease of needle and catheter insetion, quality of block on the ultrasound guided femoral nerve block
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied comparing one needle type to another on the ease and cost effectiveness of adequate ultrasound guided femoral nerve block
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 18/09/2014
Actual trial start date 30/09/2014
Anticipated date of last follow up 08/03/2015
Actual Last follow-up date 01/04/2015
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
time to onset of block, incidence of failure to introduce catheter , nerve injury as possible complications
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group nerve stimulator needle with non-stimulating catheter 30 ml of 0.25% bupivacaine cathter infusion for 3 successive days postoperatively blous and infusion of local anesthetic using nerve stimulator insulated needle to ultrasoubd guided femoral nerve block 20
Experimental Group epidural Tuohy needle with cathter 30 ml of 0.25% bupivacaine cathter infusion for 3 successive days postoperatively blous and infusion of local anesthetic using nerve stimulator insulated needle to ultrasoubd guided femoral nerve block 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients presenting for total knee replacement , ASA II-III classsification patient refusal, diabetics, neuropathy 50 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
No Medical Research Institute ethical committee
Ethics Committee Address
Street address City Postal code Country
165 Horreya street -Alhadara Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ease of needle visualization, introduction, cathterization time to visualize nerve (mapping) time for needle to reach nerve ease of cathterization
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
medical research institute 165 horreya street-Ahadara Alexandria 21556 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Institute 165 horreya street-Ahadara Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sherif A Abdelhamid 165 horreya street-Ahadara Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Medical Research Institute 165 horreya street-Ahadara Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Ahmed Abdelhamid dr_shereif@hotmail.com 002/01001459756 165 horreya road-Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt doctor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries engy yousry engi_yousry@yahoo.com 00201001459756 165 horreya road-Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt doctor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries mohamed morsy dr_shereif@hotmail.com 00201001459756 Faculty of Medicine-Alexandria University
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt assistant professor of orthopedic surgery-Faculty of medicine -Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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