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.: PACTR202509920342106 Date of Registration: 10/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Infiltration of lidocaine plus magnesium sulphate versus lidocaine alone for analgesia at episiotomy repair in Kano: a randomised controlled trial
Official scientific title Infiltration of lidocaine plus magnesium sulphate versus lidocaine alone for analgesia at episiotomy repair in Kano: a randomised controlled trial
Brief summary describing the background and objectives of the trial BACKGROUND Episiotomy the most common surgical procedure in the labour ward, involves a deliberate incision made on the perineum to widen the pelvic outlet and facilitate vaginal delivery. Perineal pain is a frequent complication of episiotomy, adversely affecting a woman’s quality of life. While lidocaine is traditionally used for analgesia during episiotomy and its repair, its effectiveness remains debatable. Magnesium sulphate, a readily available and cheap drug with anti-nociceptive properties via NMDA receptor antagonism, has shown analgesic potential and has been used as an adjunct to local anaesthetics in other contexts; however, research on magnesium sulphate as an adjunct to lidocaine for analgesia during episiotomy repair is limited. AIM AND OBJECTIVES AIM To compare the efficacy of infiltration of lidocaine plus magnesium sulphate versus lidocaine alone for analgesia during episiotomy repair among women that had vaginal delivery at Muhammad Abdullahi Wase Teaching Hospital, Kano. OBJECTIVES 1. To compare the mean pain scores at rest and with activity using the Numerical Rating Scale (NRS) at 0, 2, 4, and 6 hours post-episiotomy repair between the two study groups at Muhammad Abdullahi Wase Teaching Hospital, Kano 2. To determine and compare the proportion of participants in each group who require additional analgesia within 6 hours following episiotomy repair at Muhammad Abdullahi Wase Teaching Hospital, Kano. 3. To assess and compare patient satisfaction with pain management post-episiotomy repair between the two groups using a Likert scale at Muhammad Abdullahi Wase Teaching Hospital, Kano. 4. To compare the incidence of side effects among participants in both groups following episiotomy repair at Muhammad Abdullahi Wase Teaching Hospital, Kano.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/10/2025
Actual trial start date
Anticipated date of last follow up 20/11/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 156
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 randomization using a randomization table created by a computer software program 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 plus magnesium sulphate 11mls (75mg) of 2% lidocaine, plus 1 mL (500mg) of 50% magnesium sulphate. Infiltration will be done at the proposed site of the episiotomy. The experimental group will receive local infiltration of 11 mL (75 mg) of 2% lidocaine along with 1 mL(500mg) of 50% magnesium sulphate, resulting in a total volume of 12 mL. This dosing is based on administering 1.5 mL of lidocaine for every 2 cm of incision per layer, considering there are three layers involved in an episiotomy: the vaginal mucosa, the muscle layer, and the skin. 78
Control Group lidocaine seventy-five milligrams (75mg) of 2% lidocaine Infiltration will be at the proposed episiotomy site. Seventy-five milligrams of lidocaine (75 mg), equivalent to approximately 11 millilitres plus 1 millilitre of distilled water, will be infiltrated at the proposed episiotomy site to achieve a total volume of 12 millilitres. 78 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women who are assessed to have an episiotomy at delivery. Those who gave consent to participate in the study. Haemodynamically stable patient 1. Episiotomy that extended to third or fourth degree perineal tears, as the tissue injury is more extensive with more inflammatory response and pain; therefore, comparison may not be objective. 2. Known allergy to local anaesthetics or magnesium sulphate 3. preterm delivery 4. delivery of a dead baby 5. postpartum haemorrhage from any cause 6. chronic use of analgesics for any disease 7. labour analgesia 8. unbooked patients Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 07/03/2025 Aminu kano teaching hospital research ethics committee
Ethics Committee Address
Street address City Postal code Country
Zaria road Kano P.M.B 345 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome in this study will be perineal pain. 2minutes after intervention,2 hours after intervention,4hours after intervention and at 6hours after intervention
Secondary Outcome Level of maternal satisfaction. 6hours after intervention
Secondary Outcome Request for additional analgesia 2minutes after intervention,2hours after intervention ,4hours after intervention, 6hours after intervention
Secondary Outcome side effects 2minutes after intervention,2hours after intervention 4hours after intervention, 6hours after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Muhammad Abdullahi Wase Teaching Hospital Hospital road, Nasarawa GRA. KANO Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Fatima Ibrahim Mukhtar HOSPITAL ROAD,NASSARAWA GRA,KANO. P.M.B 3160 KANO,NIGERIA. KANO Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fatima Ibrahim Mukhtar HOSPITAL ROAD,NASSARAWA GRA,KANO. P.M.B 3160 KANO,NIGERIA. KANO Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatima Ibrahim Mukhtar fmukhtar32@gmail.com +2348032387327 Hospital Road Nassarawa, GRA.
City Postal code Country Position/Affiliation
KANO Nigeria Senior registrar department of obstetrics and gynaecology
Role Name Email Phone Street address
Scientific Enquiries Hanifah Abubakar hanniedee83@gmai.com +2347069618008 Hospital road, nassarawa GRA
City Postal code Country Position/Affiliation
KANO Nigeria consultant obstetrician and gynecologist
Role Name Email Phone Street address
Public Enquiries Fatima Ibrahim Mukhtar fmukhtar32@gmail.com +2348032387327 hospital road, nassarawa GRA
City Postal code Country Position/Affiliation
KANO Nigeria Senior Registrar department of obstetrics and gynaecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from this study may be made available to qualified researchers with a scholarly interest in post-episiotomy pain relief. Personal Health Information (PHI) will not be included in the data or samples exchanged, as they will be coded. Before sharing any data with the requesting party, the request must be approved, and any relevant contracts, such as a material transfer agreement, must be signed.nd any relevant contracts (such as a material transfer agreement) must be signed. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data can be requested starting from nine months after an item is published, and it will be available for up to 24 months. Extensions will be evaluated on an individual basis. Qualified researchers conducting scientific research may request access to the trial. Access to individual participant data (IPD) will be granted after the assessment and approval of a study proposal, which must include a statistical analysis plan (SAP) and the execution of a data sharing agreement (DSA). For more information, please contact fmukhtar32@gmail.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Eligibility Age group 03/09/2025 Correction after review Adult: 19 Year-44 Year Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 03/09/2025 Correction after reviewers comment Primary Outcome, The primary outcome in this study will be perineal pain. , 2minutes, 2 hours, 4hours and at 6hours Primary Outcome, The primary outcome in this study will be perineal pain. , 2minutes after commencement of repair, 2 hours after intervention,4hours after intervention and at 6hours after intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 03/09/2025 Correction after reviewers comment Primary Outcome, The primary outcome in this study will be perineal pain. , 2minutes after commencement of repair, 2 hours after intervention,4hours after intervention and at 6hours after intervention Primary Outcome, The primary outcome in this study will be perineal pain. , 2minutes after intervention,2 hours after intervention,4hours after intervention and at 6hours after intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 03/09/2025 Correction after review Secondary Outcome, Level of maternal satisfaction., 6hours Secondary Outcome, Level of maternal satisfaction., 6hours after intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 03/09/2025 Correction after review Secondary Outcome, Request for additional analgesia, 2minutes,2hours,4hours,6hours Secondary Outcome, Request for additional analgesia, 2minutes after commencement of repair,2hours after intervention ,4hours after intervention, 6hours after intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 03/09/2025 Correction after review Secondary Outcome, Request for additional analgesia, 2minutes after commencement of repair,2hours after intervention ,4hours after intervention, 6hours after intervention Secondary Outcome, Request for additional analgesia, 2minutes after intervention,2hours after intervention ,4hours after intervention, 6hours after intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 03/09/2025 Addressing reviewer’s comment Secondary Outcome, side effects, 2minutes,2hours,4hours,6hours Secondary Outcome, side effects, 2minutes after intervention,2hours after intervention 4hours after intervention, 6hours after intervention
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 03/09/2025 Typographical error Data from this study may be made available to qualified researchers who have a scholarly interest in post-epiData from this study may be made available to qualified researchers with a scholarly interest in post-episiotomy pain relief. Personal Health Information (PHI) will not be included in the data or samples exchanged, as they will be coded. Before sharing any data with the requesting party, the request must be approved, and any relevant contracts, such as a material transfer agreement, must be signed.nd any relevant contracts (such as a material transfer agreement) must be signed. Data from this study may be made available to qualified researchers with a scholarly interest in post-episiotomy pain relief. Personal Health Information (PHI) will not be included in the data or samples exchanged, as they will be coded. Before sharing any data with the requesting party, the request must be approved, and any relevant contracts, such as a material transfer agreement, must be signed.nd any relevant contracts (such as a material transfer agreement) must be signed.