Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201906554747665 Date of Registration: 03/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined Dorsal penile Block and Lidocaine-prilocaine Cream
Official scientific title Effectiveness of Dorsal Penile Block With or Wtihout Prior Lidocaine_Prilocaine Cream for Neonatal Circumcision: A Randomised Controlled Study
Brief summary describing the background and objectives of the trial Circumcision, the surgical removal of the prepuce, is a common surgical procedure in male neonates with rates up to 87% in Nigeria. In sub-Saharan Africa, the practice of routine neonatal circumcision is entrenched due to widespread religious and socio-cultural indications. It is therefore pertinent to ensure it is safely performed. Adequate pain management is an indispensable key to safe circumcision in neonates. Non-use or suboptimal analgesia is a cause of deleterious stress response and increased circumcision mishap. Hence, the need for a more effective analgesia during neonatal circumcision. Objective: To compare the effectiveness of dorsal penile block with or without prior lidocaine-prilocaine cream for neonatal circumcision using changes in serum cortisol, peripheral arterial oxygen saturation and pulse rate.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Dorsal penile block
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 23/11/2017
Actual trial start date 23/11/2017
Anticipated date of last follow up 23/05/2018
Actual Last follow-up date 15/06/2018
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
IRB/IEC/0004553, NHREC/27/02/2009a Ethics and Research Committee, Obafemi Awolowo University Teaching Hospitals' Complex
IRB/IEC/0004553, NHREC/27/02/2009a Ethics and Research Committee, Obafemi Awolowo University Teaching Hospitals' Complex
IRB/IEC/0004553, NHREC/27/02/2009a Ethics and Research Committee, Obafemi Awolowo University Teaching Hospitals' Complex
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 the closed-envelope technique inwhich each patient picks one envelope in succession from a basket initially containing 72 sealed envelopes.These envelopes each contain a card bearing Group I or Group II in equal numbers of 36 cards for each group. Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lidocaine Prilocaine Cream plus Dorsal Penile Nerve Block 1g LPC and 4mg/kg 1% Plain Lidocaine LPC at 1 hour before DPNB DPNB at 5 minutes before commencement of circumcision LPC+DPNB 36
Control Group DPNB alone 4mg/kg 1% Plain Lidocaine 5 minutes before circumcision DPNB alone 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Term male neonates 2. Parental consent 1. Congenital anomaly of the phallus, e.g. hypospadias, epispadias, meatal stenosis 2. Redundant prepuce for revision circumcision 3. Medical conditions like jaundice, febrile illness and untreated bleeding disorder 4. Preputial complications such as phimosis and paraphimosis New born: 0 Day-1 Month 1 Day(s) 28 Day(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 25/05/2017 Ethics and Research Committee Obafemi Awolowo University Teaching Hospitals Complex
Ethics Committee Address
Street address City Postal code Country
Ile-Ife Ile-Ife, Osun State 220212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Pulse Rate change 30 minutes before circumcision, after DPNB, after excision of prepuce and at 30 minutes after circumcision
Secondary Outcome SpO2 change 30 minutes before circumcision, after DPNB, after excision of prepuce and at 30 minutes after circumcision
Primary Outcome Serum Cortisol change 30 minutes before commencement of circumcision and at 30 minutes after excision of the prepuce
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Paediatric Surgery Unit Ile Ife 220 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ogundele Ibukunolu O. (Self) Ile-Ife Ile-Ife, Osun state 220 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ogundele Ibukunolu O. (Self) Ile-Ife Ile-Ife, Osun State 220 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Sowande Oludayo A Ile-Ife Ile-Ife, Osun State 220 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibukunolu Ogundele ogundeleibk@gmail.com 08033178797 30, Idera Street, Aiyegbami
City Postal code Country Position/Affiliation
Sagamu, Ogun State 121101 Nigeria Senior Registrar/OAUTHC Ile-Ife
Role Name Email Phone Street address
Public Enquiries Ibukunolu Ogundele ogundeleibk@gmail.com 08033178797 30, Idera Street, Aiyegbami
City Postal code Country Position/Affiliation
Sagamu, Ogun State 121101 Nigeria Senior Registrar/OAUTHC Ile-Ife
Role Name Email Phone Street address
Scientific Enquiries Oludayo Sowande oasowande@gmail.com 08037153008 Dept. of Surgery, OAUTHC Ile-Ife
City Postal code Country Position/Affiliation
Ile-Ife, Osun State 220 Nigeria Consultant Surgeon/OAUTHC Ile-Ife
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes SPSS table of participants data Statistical Analysis Plan,Study Protocol One year from June 2019 to May 2020 Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes There was increase in mean serum cortisol, decrease in mean SpO2 and increase in mean pulse rate from baseline values in all the stages of measurement in both groups. Using 2-tailed independent samples t-test analysis, the rise in mean serum cortisol was significantly lower in Group II (8.12 ±4.52 µg/dL) compared to Group I (11.42 ±7.83 µg/dL) patients (p =0.035). Also, changes in SpO2 and pulse rate were significantly less in Group II compared to Group I patients (p <0.05) except for PR changes at 30 minutes after excision of the prepuce (p =0.086). 31/05/2019 09/10/2018
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.dropbox.com/s/xryams3054tl68s/CONSORT%202010%20Statement%20%28BMJ%29.pdf?dl=0
Changes to trial information