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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: www.pactr.org

Trial no.: PACTR2010010001783449 Date registered: 2009/12/07
TRIAL DESCRIPTION
Public title The use of three methods for Cesarean delivery
Official scientific title A Randomized Comparison of Three Neuraxial Anesthetic Techniques for Elective Cesarean Section
Brief summary describing the background
and objectives of the trial
The comparison of three types of neuroxial anesthesia in cesarean delivery in pregnant women
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 90   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 created by a computer software program Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Hyperbaric bupivacaine mixed with Fentanyl 2ml .5% hyperbaric bupivacaine mixed with fentanyl 20ug intrathecally once Hyperbaric bupivacaine mixed with Fentanyl 30
Experimental group Hyperbaric bupivacaine mixed with Fentanyl intrathecally followed by routine sequential epidural inj 1ml .5% hyperbaric bupivacaine mixed with Fentanyl 20 ug intrathecally followed by routine sequential epidural injection of 10ml .5% plain bupivacaine through the epidural catheter once Hyperbaric bupivacaine mixed with Fentanyl intrathecally followed by routine sequential epidural injection of plain bupivacaine through the epidural catheter 30
Control group Control/Comparison 15ml .5% bupivacaine and fentanly 100ug epidurally 15ml .5% bupivacaine and fentanly 100ug epidurally 15ml .5% bupivacaine and fentanly 100ug epidurally 30 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Pregnant female undergoing elective caesarean section and wishes to be conscious any contraindication to regional anesthesia, sepsis, coagulopathy 18 Years 40 Years Female

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 2009/11/02 Ethical Committee of Tanta University
Ethics Committee Address
Street address City Postal code Country
El-guish Street Tanta Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intra Operative pain intre operative period
Primary Outcome degree of muscle relaxation intra-operative period
Primary Outcome occurence of hypotension, nausea and vomiting intra-operative period
Secondary Outcome post operative pain post-operative period
Secondary Outcome Neonatal score for delivered babies post operative period
Secondary Outcome recovery of motor weakness post operative period

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gynacology Dept, University Hospital El-guish Street Tanta Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University El-Guish Street Tanta Egypt
Tanta University El-Guish Street Tanta Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University El-guish Street Tanta Egypt Hospital
Primary Sponsor Tanta University El-guish Street Tanta Egypt Hospital

COLLABORATORS
Name Street address City Postal code Country
Wail E Messbah Elstaad Street Tanta Egypt
Yasser Mohamed Amr Elmahala Elkobra Elmahala Elkobra Egypt
Ayman Salah Al-dent Abdelsalam Saeeed Street Tanta Egypt
Wail E Messbah Elstaad Street Tanta Egypt
Yasser Mohamed Amr Elmahala Elkobra Elmahala Elkobra Egypt
Ayman Salah Al-dent Abdelsalam Saeeed Street Tanta Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Ayman Yousef ayman.yousef@rocketmail.com 0020103497767 0020403328004
Street address City Postal code Country Position / Affiliation
17 El-emam Moslem Street Tanta Egypt Lecturer of Anesthesiology
Role Name Email Phone Fax
Public Enquiries Dr Ayman Yousef ayman.yousef@rocketmail.com 0020103497767 0020403328004
Street address City Postal code Country Position / Affiliation
17 El-emam Moslem Street Tanta Egypt Lecturer of Anesthesiology
Role Name Email Phone Fax
Scientific Enquiries Dr Ayman Yousef ayman.yousef@rocketmail.com 0020103497767 0020403328004
Street address City Postal code Country Position / Affiliation
17 El-emam Moslem Street Tanta Egypt Lecturer of Anesthesiology