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.: PACTR201109000311318 Date of Approval: 16/08/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Anaesthesia,post spinal anaesthesia hypotension,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 08/09/2011
Actual trial start date 03/10/2011
Anticipated date of last follow up 31/01/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants)
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
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
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 Outcome Assessors
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-Treatment of Control Group
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 Age Category Minimum age Maximum 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 Year(s) 100 Year(s) 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 29/08/2011 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 Street address
Principal Investigator Karen Mbaya karen.mbaya@aku.edu +254 722 498 991 3rd parklands avenue,Nairobi
City Postal code Country Position/Affiliation
nairobi 30270-00100 Kenya principal investigator
Role Name Email Phone Street address
Public Enquiries Karen Mbaya karen.mbaya@aku.edu +254 722 498 991 3rd parklands avenue,Nairobi
City Postal code Country Position/Affiliation
nairobi 30270-00100 Kenya
Role Name Email Phone Street address
Scientific Enquiries Thikra Shariff pain.management@aku.edu +254 20 366 2785/6 3rd parklands avenue,Nairobi
City Postal code Country Position/Affiliation
nairobi 30270-00100 Kenya supervisor
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