Trial no.:	PACTR201511001346115	Date of Approval:	13/11/2015
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Use of a Mixture of Lignocaine and Bupivacaine Versus Lignocaine Alone for Male Circumcision Under Local Anesthesia at a referral hospital in Rwanda (

Official scientific title

Use of a Mixture of Lignocaine and Bupivacaine Versus Lignocaine Alone for Male Circumcision Under Local Anesthesia at a referral hospital in Rwanda (University Teaching Hospital of Butare ). A Randomized Controlled Trial

Brief summary describing the background and objectives of the trial

Introduction: Male circumcision has been shown to reduce the risk of HIV acquisition by 50 ¿ 60% and the WHO now recommends it as one of the standard methods for HIV prevention. One reason consistently cited by men for not accepting circumcision is fear of pain during the procedure. Lignocaine (which is commonly used during circumcision) requires a shorter time to achieve anesthesia but it wears off quickly; bupivacaine has a prolonged duration of action, we expect the LBmix to better control pain during and immediately after circumcision. One study on pain control during male circumcision was done in 2011 in Rakai-Uganda, comparing the use of lignocaine alone versus lignocaine mixed with bupivacaine; however, allocation of participants was not randomized. Objective: To assess pain control during and immediately after surgery with a mixture of lignocaine and bupivacaine (LBmix) compared with lignocaine alone among male circumcision service recipients at University Teaching Hospital of Butare.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Anaesthesia,pain management,Surgery

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

02/03/2015

Actual trial start date

02/03/2015

Anticipated date of last follow up

09/03/2015

Actual Last follow-up date

09/03/2015

Anticipated target sample size (number of participants)

52

Actual target sample size (number of participants)

52

Recruitment status

Stopped early/ terminated

Publication URL

not yet published

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	computer generated random sequences	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	use of a mixture of lignocaine and bupivacaine	6 milliliters	some hours	a mixture of 3mls bupivacaine 0.5% and 3mls of lignocaine 2%	26
Control Group	Lignocaine alone group	6mls	some minutes	use of Lignocaine 1% 6mls	26	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Males (15-49years) who requested circumcision Completion for informed consent (those 21 years and older consented to be enrolled in the study while participants below 21 years assented and guardians consented for them	Those with known bleeding disorders (difficult hemostasis previously) Allergy to local anesthesia		17 Year(s)	39 Year(s)	Male

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

25/02/2015

College of Medicine and Health Sciences Institutional Review Board

Ethics Committee Address
Street address	City	Postal code	Country
Kigali Health Institute	Kigali	PO Box 3286 Kigali	Rwanda

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	pain during and after surgery	in the middle of the operation ,at 0 minute post op, at 4 hours and at 8 hours post op
Secondary Outcome	additional anesthesia and additional analgesia	intraoperatively and post operatively

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
CHUB	CHUB-Road	HUYE	PO Box 254 Butare	Rwanda

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
UNIVERSITY OF RWANDA	Huye-road	HUYE	PO Box56 Butare	Rwanda

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	UNIVERSITY OF RWANDA	HUYE DISTRICT, BUTARE TOWN	HUYE	PO BOX 3286	Rwanda	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Robinson SSEBUUFU	HUYE DISTRICT, BUTARE TOWN	HUYE	PO BOX 254 Butare	Rwanda

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Alice NIRAGIRE	niralicy@gmail.com	+250788286293	KICUKIRO KIGALI
City	Postal code	Country	Position/Affiliation
Kigali		Rwanda	GENERAL SURGEON
Role	Name	Email	Phone	Street address
Scientific Enquiries	Robinson SSEBUUFU	rssebuufu@gmail.com	+250782319539	HUYE
City	Postal code	Country	Position/Affiliation
		Rwanda	GENERAL SURGEON
Role	Name	Email	Phone	Street address
Scientific Enquiries	Brenda KATEERA	bkateera@gmail.com	+250784841256	Kicukiro Kigali
City	Postal code	Country	Position/Affiliation
Kigali	PO Box 3286 Kigali	Rwanda	In charge of Grants and Research Support and Training at CMHS at University of Rwanda

REPORTING
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Changes to trial information

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