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.: PACTR202607539615815 Date of Registration: 22/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of Continuous Bupivacaine Wound Infiltration Versus Bupivacaine-Ketamine and Bupivacaine-Magnesium Admixtures for Postoperative Analgesia Following Caesarean Section Under Spinal Anaesthesia
Official scientific title Comparison of Continuous Bupivacaine Wound Infiltration Versus Bupivacaine-Ketamine and Bupivacaine-Magnesium Admixtures for Postoperative Analgesia Following Caesarean Section Under Spinal Anaesthesia
Brief summary describing the background and objectives of the trial Introduction:Postoperative pain management following caesarean section is a critical aspect of patient care, influencing recovery time, patient satisfaction, and overall outcomes. Traditional analgesic techniques often fall short in providing adequate pain relief, leading to the exploration of alternative methods. This study aims to compare the efficacy of continuous bupivacaine wound infiltration with bupivacaine-ketamine and bupivacaine-magnesium admixtures for postoperative analgesia in patients undergoing caesarean sections under spinal anaesthesia. Objectives: 1. To evaluate the effectiveness of continuous bupivacaine wound infiltration in managing postoperative pain compared to bupivacaine-ketamine and bupivacaine-magnesium admixtures. 2. To determine the time to first rescue analgesia amongst the study group 3. To assess the side effects and complications associated with each analgesic technique. 4. To determine the impact of these analgesic methods on patient satisfaction and recovery time. Methodology:This study will be a randomised controlled trial involving a sample size of 120 patients scheduled for elective caesarean sections. Participants will be divided into three groups: Group A (continuous bupivacaine wound infiltration), Group B (bupivacaine-ketamine admixture), and Group C (bupivacaine-magnesium admixture). Pain levels will be assessed using a Visual Analog Scale (VAS) at regular intervals postoperatively, alongside monitoring for side effects such as nausea, vomiting, and sedation. Additionally, patient satisfaction scores and recovery times will be recorded.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2026
Actual trial start date
Anticipated date of last follow up 21/12/2026
Actual Last follow-up date 25/01/2027
Anticipated target sample size (number of participants) 93
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 from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Bupivacaine 0.5 percent 60 ml of 0.5% bupivacaine + 60 ml of isotonic sodium chloride (total = 120) 24hours During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours 31 Active-Treatment of Control Group
Experimental Group Bupivacaine 0.5 percent with Ketamine 0.2mgperKg Ketamine 0.25 mg/kg/hr in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml). 24 hours During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours 31
Experimental Group Bupivacaine 0.5percent and Magnesium Sulphate 6000mg : 6000 mg magnesium sulphate in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml) 24 hours During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours 31
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients aged 18–40 years undergoing elective cesarean section using a Pfannenstiel incision under a subarachnoid block. 2. American Society of Anesthesiologists (ASA) physical status class II. 3. Patients capable of understanding and using the Visual Analogue Scale (VAS). 4. Patients who have consented to the study EXCLUSION CRITERIA 1. Patient refusal. 2. Known allergy to any study drug (bupivacaine, magnesium sulfate, ketamine, or morphine). 3. Compromised renal, hepatic, or cardiac function; bleeding disorder; skeletal muscle disorder; or neurological deficit. 4. History of drug or alcohol abuse. 5. Obesity (BMI > 30 kg/m²). 6. Long-term treatment with magnesium. 7. History of chronic pain or current treatment for chronic pain. 8. Patients unsuitable for subarachnoid block or cases converted to sedation or general anesthesia. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 40 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 07/03/2024 Research Ethics Committee Uniosun Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Idi Seke osogbo PMB 5000 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain score (VAS) 2, 4, 6, 12, and 24 hours
Secondary Outcome Total morphine consumption in 24 hours over 24 hours after the surgery
Secondary Outcome Time to first rescue analgesia within the first 12 hours after surgery
Secondary Outcome Incidence of adverse effects of study drugs over 24 hours after the surgery
Secondary Outcome Patient Satisfaction over 24 hours after the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Uniosun Teaching Hospital Idi Seke Osogbo 230001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ayodeji Oluwatominiyi No 55 Adekunle Lawal Street, Ilupeju Zone 2, Onward area Osogbo 230001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Ayodeji Oluwatominiyi No 55 Adekunle Lawal street, ilupeju zone 2 Osogbo 23001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayodeji Oluwatominiyi talktoay67@gmail.com +2348030568144 No 55 Adekunle Lawal Street, Ilupeju Zone 2, Onward area
City Postal code Country Position/Affiliation
Osogbo Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Olumuyiwa Ajayeoba ajayeobatope@gmail.com +2348068805517 Anaesthesia Department Uniosun Teaching Hospital, Idi Seke
City Postal code Country Position/Affiliation
Osogbo Nigeria Consultant Anaesthetist
Role Name Email Phone Street address
Scientific Enquiries Israel Kolawole kolawole.israel@gmail.com +2348033781032 Department Of Anaesthesia, University of Ilorin Teaching Hospital
City Postal code Country Position/Affiliation
Ilorin Nigeria Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) that underlie the results reported in this trial, including data dictionaries, will be made available. Additional related documents that will be available include: study protocol, statistical analysis plan, and informed consent form. Informed Consent Form Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years. Data will be shared with qualified researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Data will be shared upon execution of a data use /sharing agreement
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
Intervention Intervention List 08/07/2026 In response to the reviewer comment Control Group, Group B Bupivacaine 0.5 percent , 60 ml of 0.5% bupivacaine + 60 ml of isotonic sodium chloride (total = 120), 24hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours , 31, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 15/07/2026 Response to the reviewer's comment Control Group, Group B Bupivacaine 0.5 percent , 60 ml of 0.5% bupivacaine + 60 ml of isotonic sodium chloride (total = 120), 24hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours , 31, Active-Treatment of Control Group Control Group, Bupivacaine 0.5 percent , 60 ml of 0.5% bupivacaine + 60 ml of isotonic sodium chloride (total = 120), 24hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours , 31, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 08/07/2026 Response to the reviewer’s comments Experimental Group, Group BK, Ketamine 0.25 mg/kg/hr in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml)., 24 hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours, 31, Experimental Group, Group BK Bupivacaine 0.5 percent with Ketamine 0.2mgperKg, Ketamine 0.25 mg/kg/hr in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml)., 24 hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours, 31,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 15/07/2026 Response to the reviewer’s comments Experimental Group, Group BK Bupivacaine 0.5 percent with Ketamine 0.2mgperKg, Ketamine 0.25 mg/kg/hr in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml)., 24 hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours, 31, Experimental Group, Bupivacaine 0.5 percent with Ketamine 0.2mgperKg, Ketamine 0.25 mg/kg/hr in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml)., 24 hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours, 31,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 08/07/2026 Response to the reviewer's comments Experimental Group, Group BM, : 6000 mg magnesium sulphate in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml), 24 hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours, 31, Experimental Group, Group BM Bupivacaine 0.5percent and Magnesium Sulphate 6000mg, : 6000 mg magnesium sulphate in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml), 24 hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours, 31,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 15/07/2026 Response to the reviewer's comments Experimental Group, Group BM Bupivacaine 0.5percent and Magnesium Sulphate 6000mg, : 6000 mg magnesium sulphate in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml), 24 hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours, 31, Experimental Group, Bupivacaine 0.5percent and Magnesium Sulphate 6000mg, : 6000 mg magnesium sulphate in 60 ml saline + 30 ml of 0.5% bupivacaine + 30 ml saline (total = 120 ml), 24 hours, During skin closure at the end of surgery, wound catheter is placed aseptically by surgeon, and continuous wound infiltration started via an elastomeric pump at 5ml/hour for 24 hours, 31,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2026 The previous ethical approval needed march2026, this is the extended copy TRUE, Research Ethics Committee Uniosun Teaching Hospital, Idi Seke , osogbo, PMB 5000, Nigeria, , 07 Mar 2024, +2347033328615, researchethicscommittee.uth@yahoo.com, 43607_39921_4737.pdf TRUE, Research Ethics Committee Uniosun Teaching Hospital, Idi Seke , osogbo, PMB 5000, Nigeria, , 07 Mar 2024, +2347033328615, researchethicscommittee.uth@yahoo.com, 43607_39921_4737.pdf