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.: PACTR201703002099811 Date of Approval: 13/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison Of Three Different Concentrations of Levobupivacaine for epidural labour analgesia: Clinical Effect and Pharmacokinetic Profile
Official scientific title Comparison Of Three Different Concentrations of Levobupivacaine for epidural labour analgesia: Clinical Effect and Pharmacokinetic Profile
Brief summary describing the background and objectives of the trial This study was designed to compare the clinical effect of different concentrations of levobupivacaine (0.25%, 0.125% and 0.0625%) for epidural labour analgesia and to determine the plasma level achieved with each concentration.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 11/11/2015
Actual trial start date 11/11/2015
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 31/12/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Simple randomisation using a radomisation table created by a computer software program Using randomization code Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ¿ Group 1(n = 20): received epidural levobupivacaine 0.25%. ¿ Group 1(n = 20): received epidural levobupivacaine 0.25%. ¿ Group 1(n = 20): received epidural levobupivacaine 0.25%. ¿ Group 1(n = 20): received epidural levobupivacaine 0.25%. 20 Active-Treatment of Control Group
Experimental Group ¿ Group 2(n = 20) : received epidural levobupivacaine 0.125% ¿ Group 2(n = 20) : received epidural levobupivacaine 0.125% ¿ Group 2(n = 20) : received epidural levobupivacaine 0.125% ¿ Group 2(n = 20) : received epidural levobupivacaine 0.125% 20 Active-Treatment of Control Group
Experimental Group ¿ Group 3(n = 20): received epidural levobupivacaine 0.0625%. ¿ Group 3(n = 20): received epidural levobupivacaine 0.0625%. ¿ Group 3(n = 20): received epidural levobupivacaine 0.0625%. ¿ Group 3(n = 20): received epidural levobupivacaine 0.0625%. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The parturients were 20 to 40 years of age with vertex presentation and cervical dilatation less than 4 cm and having at least one contraction every 5 minutes, with gestational age more than 38 weeks Parturients with hypertensive disorders of pregnancy (e.g., pre-eclampsia and eclampsia) or with a history of cardiac, liver, or kidney diseases were excluded from the study. Subjects with history of allergy to amide local anesthetics were also excluded. 20 Year(s) 40 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 10/11/2015 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
mokbel,mohamad anwar hassan street, 62511 BeniSuief 000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Sensory block characteristics The onset of sensory block was determined by the time from injection of the epidural bolus dose till the occurrence of the first painless contraction and the achievement of VAS less than 3. The VAS was assessed at 30 minutes interval till delivery 1- Sensory block characteristics The onset of sensory block was determined by the time from injection of the epidural bolus dose till the occurrence of the first painless contraction and the achievement of VAS less than 3. The VAS was assessed at 30 minutes interval till delivery
Secondary Outcome The motor block The motor block was assessed according to the modified Bromage scale The motor block The motor block was assessed according to the modified Bromage scale
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni-Suef University hospital mokbel,mohamad anwar hassan street, 62511 BeniSuief 000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding Egypt BeniSuief Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Shehta Asfour egypt,benisuef governerate ,mokbel,mohamad anwar hassan street, 62511 BeniSuief University hospital,Egypt 000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
doaa rashwan egypt,benisuef governerate ,mokbel,mohamad anwar hassan street, 62511 BeniSuief University hospital,Egypt 000 Egypt
Hatem Elmoutaz BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Asfour doaa_rashwan@hotmail.com 00201011270762 BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief 000 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief University hospital,Egypt 000 Egypt Assitant professor
Role Name Email Phone Street address
Scientific Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief University hospital,Egypt 000 Egypt Assitant professor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information