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.: PACTR201306000548170 Date of Approval: 11/05/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
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 post dural puncture headache,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2013
Actual trial start date 03/06/2013
Anticipated date of last follow up 01/07/2013
Actual Last follow-up date 06/07/2013
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 66
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Care giver/Provider,Participants
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 Age Category Minimum age Maximum 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 Year(s) 45 Year(s) 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 15/12/2012 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 Street address
Principal Investigator Hassan Ali hassan364@hotmail.com +201001733687 kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt.
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Hassan Ali hassan364@hotmail.com +201001733687 kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo ¿Egypt.
City Postal code Country Position/Affiliation
Cairo 1234 Egypt lecturer of anesthesia-Cairo university
Role Name Email Phone Street address
Scientific Enquiries Mohamed mourad Mourad50009@yahoo.com +201227126960 kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo ¿Egypt.
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of anesthesia
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