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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: www.pactr.org

Trial no.: PACTR201109000311318 Date registered: 2011/08/16
TRIAL DESCRIPTION
Public title spinal anaesthesia at L3,4 interspace vs L5,S1 interspace
Official scientific title A RANDOMISED CONTROLLED TRIAL COMPARING HAEMODYNAMIC STABILITY IN ELDERLY PATIENTS UNDERGOING SPINAL ANESTHESIA AT L5,S1 VERSUS SPINAL ANESTHESIA AT L3,4
Brief summary describing the background
and objectives of the trial
Spinal anaesthesia(SA) is routinely performed for elderly patients.SA,performed at the conventional level-L3,4 interspace is associated with 65%incidence of hypotension.these patients are generally elderly and haemodynamic stability is of primary importance for good outcomes.this study aims to investigate the difference in haemodynamic stability between elderly patients who have SA at L3,4 and those who have SA at L5,S1.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2011-09-08
Actual trial start date 2011-10-03
Anticipated date of last follow up 2012-01-31
Actual date of last follow up
Anticipated target sample size (number of participants) 32   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 computer generated sequence of numbers(table) sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Group 1 (Standard block) 2.5mls .5 percent hyperbaric bupivacaine single injection intrathecally injected at the L3, 4 interspace 16 Active
Experimental group Group 2 (low block) 2.5mls .5 percent hyperbaric bupivacaine single injection intrathecally injected at the L5, S1 interspace 16

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
All patients scheduled for transurethral resection of the prostate under spinal anaesthesia during the period 1 October 2011 to 31 December 2011 will be eligible. All ASA I - III patients,above 60yrs scheduled for surgery under spinal anaesthesia during this period. 1. Patient refusal to participate 2. Contraindication to spinal anaesthesia a. coagulopathy b. hypovolemia/shock c. increased intracranial pressure d. sepsis e. infection at the puncture site 3. Severe cardiac disease graded as NYHA III - IV 60 Years 100 Years Both

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 2011/08/29 aga khan university hopsital,nairobi,kenya
Ethics Committee Address
Street address City Postal code Country
3rd parklands avenue,nairobi nairobi,kenya 30270-00100 Kenya

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to compare the proportion of hypotension between elderly patients who undergo spinal anaesthesia at L3,4 and those who undergo spinal anaesthesia at L5,S1 blood pressures will be compared up to 45 min after administration of the spinal anaesthetic

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AGA KHAN UNIVERSITY HOSPITAL,NAIROBI,KENYA 3rd parklands avenue,nairobi,kenya Nairobi 30270-00100 Kenya

FUNDING SOURCES
Name of source Street address City Postal code Country
aga khan university hospital,nairobi 3rd parklands avenue,nairobi,kenya Nairobi 30270-00100 Kenya

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor aga khan university hospital,nairobi 3rd parklands avenue,nairobi,kenya Nairobi 30270-00100 Kenya University

COLLABORATORS
Name Street address City Postal code Country
dr thikra shariff 3rd parklands avenue,nairobi,kenya Nairobi 30270-00100 Kenya
dr dorothy kamya 3rd parklands avenue,nairobi,kenya Nairobi 30270-00100 Kenya
dr vitalis mung'ayi 3rd parklands avenue,nairobi,kenya Nairobi 30270-00100 Kenya

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Karen Mbaya karen.mbaya@aku.edu +254 722 498 991
Street address City Postal code Country Position / Affiliation
3rd parklands avenue,Nairobi nairobi 30270-00100 Kenya principal investigator
Role Name Email Phone Fax
Scientific Enquiries Dr Thikra Shariff pain.management@aku.edu +254 20 366 2785/6
Street address City Postal code Country Position / Affiliation
3rd parklands avenue,Nairobi nairobi 30270-00100 Kenya supervisor
Role Name Email Phone Fax
Public Enquiries Dr Karen Mbaya karen.mbaya@aku.edu +254 722 498 991
Street address City Postal code Country Position / Affiliation
3rd parklands avenue,Nairobi nairobi 30270-00100 Kenya