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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201306000510382 |
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Date of registration:
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26/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Transient Neurologic Symptoms following spinal Lignocaine and Bupivacaine for caesarean delivery at Mulago Hospital, a randomised trial.
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Scientific title:
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Transient Neurologic symptoms following spinal lignocaine and bupivacaine for caesarean delivery in mulago hospital, a randomised trial. |
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Date of first enrolment:
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20/03/2013 |
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Target sample size:
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180 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=510 |
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Study type:
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Interventional |
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Study design:
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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.
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Phase:
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Not Applicable
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Agnes
Wabule |
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Address:
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mulago hospital
P O Box 7072
Kampala
Uganda |
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Telephone:
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+256-712-852 137 |
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Email:
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aggiewabule2000@yahoo.co.uk |
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Affiliation:
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Lecturer |
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Name:
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Arthur
Kwizera |
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Address:
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mulago hospital
P O Box 7072
Kampala
Uganda |
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Telephone:
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+256-772-897171 |
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Email:
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kwizera.arthur@gmail.com |
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Affiliation:
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Lecturer |
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Key inclusion & exclusion criteria
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Inclusion criteria: only ASA 1 and 2 and E , patients above 18 and provide informed consent to participate in the study will be enrolled.
Exclusion criteria: 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.
Age minimum:
18 Year(s)
Age maximum:
40 Year(s)
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Nervous System Diseases
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its comparing safety profile for the different drugs in the randomised trial.
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Nervous System Diseases
its comparing safety profile for the different drugs in the randomised trial.
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Intervention(s)
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Bupivacaine
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Lignocaine
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Primary Outcome(s)
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to compare the incidence of transient neurologic symptoms in either bupivacaine or lignocaine arms
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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mulago teaching hospital
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Ethics review
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Status: Not approved
Approval date:
Contact:
School of Medicine Research and Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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