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.: PACTR201609001782787 Date of Approval: 16/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title MEV of bupivacaine for spinal anesthesia
Official scientific title Minimum effective volume of bupivacaine in spinal anesthesia for elective cesarean section. Does it differ with height?
Brief summary describing the background and objectives of the trial This study aims to determine the minimum effective volume of hyperbaric bupivacaine 0.5% with fentanyl in 90% of parturients (MEV90) with different height groups undergoing cesarean section.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Pregnancy and Childbirth,spinal anesthesia for cesarean section
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2016
Actual trial start date 01/01/2016
Anticipated date of last follow up 01/06/2016
Actual Last follow-up date 01/09/2016
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 201
Recruitment status Completed
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 Stratified allocation based on participants height By holder of the sequence Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group bupivacaine plus fentanyl according to the response of the previous participant once for spinal anesthesia spinal anesthesia 64
Experimental Group bupivacaine plus fentanyl according to the response of the previous participant once for spinal anesthesia spinal anesthesia 71
Experimental Group bupivacaine plus fentanyl according to the response of the previous participant once for spinal anesthesia spinal anesthesia 66
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
we included parturients scheduled for elective caesarean section under spinal anesthesia to one of 3 groups according to their height(ht), group 1 including those with height between 150 to 159 cm, group 2 with ht between 160 and 169 cm and group 3 patients with ht between 170 and 179 cm. All the included parturients were ASA I or II having a singleton beyond 36 weeks¿ pregnancy We excluded all those with ht below 150 or above 179 cm, those with body mass index (BMI) above 30, with essential or pregnancy-induced hypertension, any neurological diseases, and those receiving any medications affecting the cardiovascular system. We also excluded those with polyhydramnios, multiple gestation, having fetus with congenital anomalies and those with any contraindication to spinal anesthesia 20 Year(s) 40 Year(s) Male
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 17/09/2016 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Ramses street Cairo 11522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Minimum effective volume of bupivacaine in spinal anesthesia for elective Cesarean section for different height groups At the end of the trial
Secondary Outcome Level of motor and sensory block Every 2 minutes for 10 minutes
Secondary Outcome Hemodynamic parameters Every 2 minutes for 10 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University hospital Abbasia Cairo 11522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University hospital Abbasia Cairo 11522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ramses street Cairo 11522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Walid Nofal Heliopolis Cairo 11251 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walid Nofal w201077@yahoo.com 00201097121743 1 Abdel Hamid Badawy street Heliopolis
City Postal code Country Position/Affiliation
Cairo 11251 Egypt Lecturer of Anesthesiology
Role Name Email Phone Street address
Public Enquiries Walid Nofal w201077@yahoo.com 00201097121743 1 Abdel Hamid Badawy street Heliopolis
City Postal code Country Position/Affiliation
Cairo 11251 Egypt Lecturer of Anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Walid Nofal w201077@yahoo.com 00201097121743 1 Abdel Hamid Badawy street Heliopolis
City Postal code Country Position/Affiliation
Cairo 11251 Egypt Lecturer of Anesthesiology
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