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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201304000495942 Date of Registration: 07/02/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Vocal local versus pharmacological treatments for pain management in tubal ligation procedures in rural Kenya: a non-inferiority trial
Official scientific title Vocal local versus pharmacological treatments for pain management in tubal ligation procedures in rural Kenya: a site-randomised non-inferiority trial
Brief summary describing the background and objectives of the trial The Vocal local approach uses distraction and relaxation techniques instead of pharmacological analgesics to help women manage pain during tubal ligation, but its effectiveness has not been evaluated. This site-randomised non-inferiority trial measures the effectiveness of VL and local anaesthesia (LA) (control) versus VL and LA with additional opioid analgesics (intervention), on pain and satisfaction levels in 884 women undergoing tubal ligation in 40 outreach clinics in rural Kenya.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pain during tubal ligation
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Supportive care
Anticipated trial start date 06/02/2012
Actual trial start date 06/02/2012
Anticipated date of last follow up 14/07/2012
Actual Last follow-up date 14/07/2012
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 884
Recruitment status Completed
Publication URL http://www.biomedcentral.com/1472-6874/14/21
Secondary Ids Issuing authority/Trial register
KU/R/COMM/51/25 Ethical Review Committee of Kenyatta University (KU-ERC)
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group VL+local anaesthetic+analgesics local anaesthetic: 10ml of 2% lignocaine; analgesic: 50mg tramadol hydrochloride one administration 30 mins prior to procedure The vocal local technique uses distraction and relaxation to manage pain throughout the procedure and during recovery. This was coupled with a local anaesthetic and an analgesic administered 30 mins prior to their tubal ligation procedure 423 Active-Treatment of Control Group
Experimental Group VL+local anaesthetic local anaesthetic: 10ml of 2% lignocaine one administration 30 mins prior to procedure The vocal local technique uses distraction and relaxation to manage pain throughout the procedure and during recovery. This was coupled with a local anaesthetic but no analgesic. 461 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Tubal ligation clients Uncontrolled epilepsy Recent head injury Renal impairment Hypotension Sexually transmitted infections 18 Year(s) 50 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 09/11/2011 Ethical Review Committee of Kenyatta University (KU-ERC)
Ethics Committee Address
Street address City Postal code Country
Kenyatta University, P.O. Box. 43884-00100 Nairobi Kenya
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 MSI independent Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
MSI, 1 Conway Street, Fitzroy Square London W1T 6LP United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain During the procedure (retrospective reporting) At most painful moment (retrospective reporting) After procedure (at time of interview)
Secondary Outcome Satisfaction with procedure At time of interview (after procedure)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rural mobile outreach clinics Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
USAID Washington D.C. United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Marie Stopes International 1 Conway, Fitzroy Sq London W1T 6LP United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Sarah Keogh 1 Conway, Fitzroy Sq London W1T 6LP United Kingdom
Thoai Ngo 1 Conway, Fitzroy Sq London W1T 6LP United Kingdom
Kenzo Fry 1 Conway, Fitzroy Sq London W1T 6LP United Kingdom
Edwin Mbugua Marie Stopes Kenya Nairobi Kenya
Heidi Quinn 1 Conway, Fitzroy Sq London W1T 6LP United Kingdom
George Otieno Kenyatta University Nairobi Kenya
Mark Ayallo Marie Stopes Kenya Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Thoai Ngo thoai.ngo@mariestopes.org +44 (0)20 7034 2352 1 Conway St, Fitzroy Sq
City Postal code Country Position/Affiliation
London W1T 6LP United Kingdom Head of Research
Role Name Email Phone Street address
Public Enquiries Thoai Ngo thoai.ngo@mariestopes.org +44 (0)20 7034 2352 1 Conway St, Fitzroy Sq
City Postal code Country Position/Affiliation
London W1T 6LP United Kingdom Head of Research
Role Name Email Phone Street address
Scientific Enquiries Thoai Ngo thoai.ngo@mariestopes.org +44 (0)20 7034 2352 1 Conway St, Fitzroy Sq
City Postal code Country Position/Affiliation
London W1T 6LP United Kingdom Head of Research
REPORTING
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