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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.: PACTR201306000548170 Date registered: 2013/05/11
TRIAL DESCRIPTION
Public title Intravenous infusion of Adrenaline to decrease the incidence of post dural puncture headache after spinal anesthesia for cesarean section
Official scientific title Intravenous infusion of Adrenaline to decrease the incidence of post dural puncture headache after spinal anesthesia for cesarean section
Brief summary describing the background
and objectives of the trial
post dural puncture headache (PDPH) is a well known complication of spinal anesthesia ,its etiology has many theories ,cranial vessels is one of them ,that is why vasoconstrictors are used in its treatment. This study aims at examining if adrenaline as a vasoconstrictor can be used safely as a prophylaxis of PDPH.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2013-06-01
Actual trial start date 2013-06-03
Anticipated date of last follow up 2013-07-01
Actual date of last follow up 2013-07-06
Anticipated target sample size (number of participants) 66   
Actual target sample size (number of participants) 66   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
6/2013 anesthesia REC

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 - coin-tossing Allocated blindly by giving patient a no. that is secret to follow-up provider and clear to principle investigator Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group adrenaline infusion 0.02-0.1 mic/kg/min 45min Intravenous infusion of Adrenaline to decrease the incidence of post dural puncture headache after spinal anesthesia for cesarean section 33 Placebo
Control group ringer infusion 500cc 45min ringer infusion as a placepo 33 Placebo
Experimental group adrenaline infusion 0.02-0.1 mic/kg/min 45min Intravenous infusion of Adrenaline to decrease the incidence of post dural puncture headache after spinal anesthesia for cesarean section 120 Placebo
Control group ringer infusion 500cc 45min placebo 120 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Any full term pregnant patient with single infant indicated for elective section under spinal anesthesia with no history of medical importance was included Any full term pregnant patient with multiple infant indicated for elective section under spinal anesthesia with history of medical importance was excluded 18 Years 45 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 2012/12/15 anesthesia department
Ethics Committee Address
Street address City Postal code Country
kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt. Cairo Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome decrease headache incidence one,three and seven days post operative
Secondary Outcome adrenaline safety in pregnancy 45 minutes regarding arrhythmia,fetal outcome,angina pain

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university-faculty of medicine-teaching hospital kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt. Cairo 1234 Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Cair univesity . kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt. Cairo Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesia department kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt. Cairo Egypt University

COLLABORATORS
Name Street address City Postal code Country
Mohamed Mourad Hashim kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt. Cairo Egypt
Eissa Ahmed Ibrahim kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt. Cairo Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Dr Hassan Ali hassan364@hotmail.com +201001733687
Street address City Postal code Country Position / Affiliation
kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo ¿Egypt. Cairo 1234 Egypt lecturer of anesthesia-Cairo university
Role Name Email Phone Fax
Principal Investigator Dr Hassan Ali hassan364@hotmail.com +201001733687
Street address City Postal code Country Position / Affiliation
kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt. Cairo Egypt lecturer of anesthesia
Role Name Email Phone Fax
Scientific Enquiries Dr Mohamed mourad Mourad50009@yahoo.com +201227126960
Street address City Postal code Country Position / Affiliation
kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo ¿Egypt. Cairo Egypt lecturer of anesthesia