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.: PACTR201306000510382 Date of Approval: 26/02/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Transient Neurologic Symptoms following spinal Lignocaine and Bupivacaine for caesarean delivery at Mulago Hospital, a randomised trial.
Official scientific title Transient Neurologic symptoms following spinal lignocaine and bupivacaine for caesarean delivery in mulago hospital, a randomised trial.
Brief summary describing the background and objectives of the trial A Random Control Trial , single blind comparing spinal Lignocaine and Bupivacaine in the causation of transient neurologic symptoms in mothers for caesarean delivery in mulago hospital. Objectives:; -The study will determine the incidence of transient neurologic symptoms in both Lignocaine and Bupivacaine. -The study will also assess for risk factors that lead to development of transient neurologic symptoms in either arm.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SLAB TNS
Disease(s) or condition(s) being studied its comparing safety profile for the different drugs in the randomised trial.,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/03/2013
Actual trial start date 27/03/2013
Anticipated date of last follow up 03/05/2013
Actual Last follow-up date 10/05/2013
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 150
Recruitment status Not yet recruiting
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
Randomised Randomisation for the study clients will be randomised in either arm by computer generated numbers , using computer software the allocation code will be concealled from the patients by using a sealed opaque envelope. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Randomisation for the study clients will be randomised in either arm by computer generated numbers , using computer software the allocation code will be concealled from the patients by using a sealed opaque envelope. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lignocaine 5% spinal lignocaine 75mg, drug is admnistered before the caesarean section , drug lasts about 90 minutes the drug will be administered to facilitate the delivery of the baby and the mother will be assessed for the development of transient neurological symptoms 24-72 hours. 90 Active-Treatment of Control Group
Control Group Bupivacaine 0.5%, 10mg 4-6 hrs Drug will be given to aid delivery of baby by C-section. Later 24-72hrs patients will be assessed for existence of TNS 90 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
only ASA 1 and 2 and E , patients above 18 and provide informed consent to participate in the study will be enrolled. Patients with previous neurologic deficits, periperal neuropathy like diabetes, previous back injuries. Failed spinal :patients who receive spinal blockade with either Lignocaine or Bupivacaine, and the drug fails to take, then get general anaesthesia will be excluded. 18 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
No 06/02/2013 School of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Makerere college of health science Kampala P.O Box 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to compare the incidence of transient neurologic symptoms in either bupivacaine or lignocaine arms the existance of transient neurologic symptoms will be measured from 24 hours to 72 hours post spinal block
Secondary Outcome Patients will be asseddes for factors that may contribute to the existence of TNS like needle type, number of attempts at spinal, Age and weight. These will be analysed at the end in either arms of the study. The outcome will be calculated with Poisson distribution This information will be filled at the start, before the stuy drug is administered.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago teaching hospital labour suite wards Mulago hospital Kampala p.o.box 7072 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
mulago teaching hospital Mulago hospital kampala p.o.box 7072 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Aggrey Lubikire(self) Mulago hospital kampala p.o.box 7072 Uganda Hospital
Secondary Sponsor mulago teaching hospital Mulago hospital kampala p.o.box 7072 Uganda Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Arthur Kwizera Mulago hospital kampala p.o.box 7072 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aggrey Lubikire aggreylub@googlemail.com +256-756-720972 mulago hospital
City Postal code Country Position/Affiliation
Kampala P O Box 7072 Uganda final year student
Role Name Email Phone Street address
Public Enquiries Arthur Kwizera kwizera.arthur@gmail.com +256-772-897171 mulago hospital
City Postal code Country Position/Affiliation
Kampala P O Box 7072 Uganda Lecturer
Role Name Email Phone Street address
Scientific Enquiries Agnes Wabule aggiewabule2000@yahoo.co.uk +256-712-852 137 mulago hospital
City Postal code Country Position/Affiliation
Kampala P O Box 7072 Uganda Lecturer
REPORTING
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