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.: PACTR202508902692676 Date of Registration: 07/08/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lidocaine-prilocaine cream versus lidocaine injection for top-up for pain relief during episiotomy repair after vaginal delivery at the University of Maiduguri Teaching Hospital: a randomised controlled trial
Official scientific title Lidocaine-prilocaine cream versus lidocaine injection for top-up for pain relief during episiotomy repair after vaginal delivery at the University of Maiduguri Teaching Hospital: a randomised controlled trial
Brief summary describing the background and objectives of the trial Background: One of the most prevalent issues that women may have during vaginal delivery is perineal trauma. The trauma can either be inadvertent (tear) or intentional (episiotomy). This trauma is associated with perineal pain which is one of the most common causes of maternal morbidity in the early puerperium. When repair of perineal trauma is required, adequate analgesia must be acheived. Aim: To compare the efficacy and safety of topically applied lidocaine-prilocaine cream with lidocaine injection for Top-up for pain relief during episiotomy repair after vaginal delivery. Methodology: This will be a randomized equivalence-controlled study that will compare the efficacy and safety of lidocaine-prilocaine cream with lidocaine injection for top-up for pain relief during episiotomy repair after vaginal delivery at the University of Maiduguri Teaching Hospital (UMTH), Maiduguri. Eighty (80) eligible and consenting participants in all will be randomly assigned to one of two groups, Group A or Group B. Participants in Group A will receive lidocaine-prilocaine cream 5 grams (gr) which will be applied to the healthy skin around the episiotomy site and suturing will begin after 10 minutes of application of the cream. For Group B, all eligible participants will receive 5mls of 2% lidocaine which will be injected to the episiotomy incision line and suturing will begin after 10 minutes. If more analgesia is needed during suturing, 5mls of lidocaine 2% will be used in both groups
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2025
Actual trial start date 15/10/2025
Anticipated date of last follow up 01/04/2026
Actual Last follow-up date 15/04/2026
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Not yet recruiting
Publication URL Research has not commenced. Hence, no publication URL for now
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 Permuted block randomization 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 Lidocaine prilocaine cream group All eligible participants in Group A will be given lidocaine-prilocaine cream during perineal repair which is a 30gram topical cream which is packed in 5gram sterile tubes. In this lidocaine-prilocaine cream group, 5gram of the cream will be applied to the healthy skin around the episiotomy site and repair will begin after 10 minutes of application of the lidocaine cream. In case of active bleeding, packed method will be used. The lidocaine prilocaine cream will be applied 10 minutes before commencement of repair for participants in Group A. All eligible participants in Group A will be given lidocaine-prilocaine cream during perineal repair which is a 30gram topical cream which is packed in 5gram sterile tubes. In this lidocaine-prilocaine cream group, 5gram of the cream will be applied to the healthy skin around the episiotomy site and repair will begin after 10 minutes of application of the lidocaine cream. In case of active bleeding, packed method will be used. 40
Control Group Lidocaine injection group B For Group B, all eligible participants will receive 5mls of 2% lidocaine which will be infiltrated along the intended site to be repaired and repair will be done after 10 minutes. If more analgesia is needed during suturing, 5mls of 2% lidocaine injection will be used in both groups. For Group B, all eligible participants will receive 5mls of 2% lidocaine which will be infiltrated along the intended site to be repaired and repair will be done after 10 minutes. If more analgesia is needed during suturing, 5mls of 2% lidocaine injection will be used in both groups. For Group B, all eligible participants will receive 5mls of 2% lidocaine which will be infiltrated along the intended site to be repaired and repair will be done after 10 minutes. If more analgesia is needed during suturing, 5mls of 2% lidocaine injection will be used in both groups. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following inclusion criteria will be applied: 1) Gestational age greater than or equal to 37 weeks 2) Singleton pregnancy 3) Cephalic presentation/ Vertex The following criteria will be excluded: 1) Epidural analgesia 2) Operative delivery 3) Previous adverse reaction to a local anaesthetic 4) Cervical tear 5) 3rd or 4th degree perineal tear 6) Neurological disease which affects the lower limb 7) Heart disease 8) Uncontrolled Diabetes mellitus Adult: 19 Year-44 Year 19 Year(s) 44 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 11/06/2025 Research and Ethics Committee University of Maiduguri Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
P M B 1414 Bama Road Maiduguri Borno State Nigeria Maiduguri 600211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of this study is to determine and compare participant pain perception when either lidocaine cream or lidocaine infiltration is given for top-up for pain relief during episiotomy repair following vaginal delivery. Within the first 5 minutes of repair
Secondary Outcome The secondary outcome measures will be the need for rescue analgesia, duration of repair with each method, patient’s satisfaction, rate of adverse effects of both medications and post-partum complications (wound infection). During repair, after repair and 1 week post-partum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Maiduguri Teaching Hospital Maiduguri Borno State Nigeria P MB 1414 Bama road Maiduguri Borno State Nigeria Maiduguri 600211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Edward Sunday the researcher. There is no funding from any source for the research. The researcher will provide all that is needed for the research. Forri street, Maiduguri, Borno State, Nigeria Maiduguri 600211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Edward Sunday the researcher. No other sponsoship for the research Forri Street, Maiduguri, Borno State, Nigeria Maiduguri 600211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edward Sunday eddysunday.013@gmail.com +2348036996395 Forri street, Maiduguri, Borno State Nigeria
City Postal code Country Position/Affiliation
Maiduguri 600211 Nigeria Senior Registrar in Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Abraham Okoihue aokoihue@gmail.com +2348063176288 Maisandari Street, Maiduguri, Borno State, Nigeria
City Postal code Country Position/Affiliation
Maiduguri 600211 Nigeria Drugfield pharmaceutical company drug representative
Role Name Email Phone Street address
Scientific Enquiries Gideon Malgwi malgwigidds89@gmail.com +2347033278713 UMTH Staff Quarters
City Postal code Country Position/Affiliation
Maiduguri 600211 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes -Will individual participant data be available? Yes -What data in particular will be shared? Individual participant data that underlie the results that will be reported in the article after deidentification (text, tables, figures and appendices) -What other documents will be available? Study protocol, statistical analysis and informed consent -When will data be available? Immediately following publications. No end date. -With whom? Anyone who wishes to assess the data -By what mechanism will data be made available? Data will be made available indefinitely (link will subsequently be provided) - Informed Consent Form,Statistical Analysis Plan,Study Protocol The time frame is 6 months from the time of commencement of the research after it has been approved by the National Post-graduate Medical College of Nigeria (NPMCN) Keywords: Episiotomy, Lidocaine-Prilocaine cream, Lidocaine injection, Pain, Vaginal delivery, Maiduguri
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No yet No
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 07/08/2025 PACTR Admin LIDOCAINE-PRILOCAINE CREAM VERSUS LIDOCAINE INJECTION FOR TOP-UP FOR PAIN RELIEF DURING EPISIOTOMY REPAIR AFTER VAGINAL DELIVERY AT THE UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL: A RANDOMISED CONTROLLED TRIAL Lidocaine-prilocaine cream versus lidocaine injection for top-up for pain relief during episiotomy repair after vaginal delivery at the University of Maiduguri Teaching Hospital: a randomised controlled trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 07/08/2025 PACTR Admin LIDOCAINE-PRILOCAINE CREAM VERSUS LIDOCAINE INJECTION FOR TOP-UP FOR PAIN RELIEF DURING EPISIOTOMY REPAIR AFTER VAGINAL DELIVERY AT THE UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL: A RANDOMISED CONTROLLED TRIAL Lidocaine-prilocaine cream versus lidocaine injection for top-up for pain relief during episiotomy repair after vaginal delivery at the University of Maiduguri Teaching Hospital: a randomised controlled trial