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.: PACTR202404745779132 Date of Approval: 08/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Randomised Controlled Study Of The Effectiveness Of Wound Infiltration With Bupivacaine in Post Caesarean Section Analgesia In Kwara State Teaching Hospital, Ilorin
Official scientific title Randomised Controlled Study Of The Effectiveness Of Wound Infiltration With Bupivacaine in Post Caesarean Section Analgesia In Kwara State Teaching Hospital, Ilorin
Brief summary describing the background and objectives of the trial Caesarean section (CS) is a common obstetric operation performed worldwide. Effective management of post caesarean section pain is important for the well-being of mother and child. Though, opioids with epidural route is considered as most preferred and most effective form of analgesia following CS, it is however expensive, not readily available and associated with some side effects. Hence, use of systemic opioids, which also have some side effects that can militate against the role of mother (breastfeeding and maternal-neonate bond) in early post operative period. Bupivacaine wound infiltration post CS can serve as supplemental analgesics that can help reduce the quantity of opioids used post operatively. Aim The study is to assess the efficacy of wound infiltration with bupivacaine as post caesarean section analgesia at Kwara state teaching hospital,Ilorin. General objective The study’s aim is to assess the analgesic efficacy of bupivacaine wound infiltration in post caesarean section analgesia. Specific objectives 1. To review the recent available literatures on the effectiveness of bupivacaine wound infiltration. 2. To compare the postoperative time to first analgesic request between the study groups and control. 3. To compare the pain score using the numerical rating scale, the cumulative amount of rescue analgesia consumed and side effects/complications between the study groups and control 4. To compare the postoperative time of mobility/ambulation, breastfeeding, mother-to-baby attachment, cost-benefit analysis and maternal satisfactions among the study groups and control. 5. To make recommendation(s) on bupivacaine wound infiltration as post caesarean section analgesia based on the findings from objectives 2, 3 and 4 above.
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 20/10/2023
Actual trial start date 23/10/2023
Anticipated date of last follow up 21/03/2024
Actual Last follow-up date 06/04/2024
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
UITHCAT18924013 UITH ETHICAL RESEARCH COMMITTEE
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Bupivacaine infiltration on the subcutaneous layer group Group A: Bupivacaine wound infiltration into the subcutaneous layer only (20mls on each of the upper and lower edges of the wound + intravenous acetaminophen (paracetamol) 1g. Given at wound closure during caesarean section A local anaesthetic; bupivacaine as postcaesarean section analgesia 36
Experimental Group GROUP B Bupivacaine infiltration into the subcutaneous layer and sub fascia (10mls into each of the upper and lower edges of the wound at the subcutaneous layer and subfascia respectively) + intravenous acetaminophen (paracetamol) 1g 24 hours duration post caesarean section pain management post caesarean section 36
Control Group Group C Group C: placebo (normal saline) infiltration in to the subcutaneous layer only (20mls on each of the upper and lower edges of the wound) + intravenous acetaminophen (paracetamol) 1g. then 1g of paracetamol 6hourly for the next 24 hours 24 hours post caesarean section Group C 36 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting pregnant women for elective or emergency caesarean section with live fetuses under subarachnoid block (regardless of numbers of previous caesarean delivery). Patients that: 1. Are not able to understand or use the pain scoring system (mentally retarded, behavioural disorders). 2. Have proven or suspected allergy to local anaesthetics, pentazocine or paracetamol 3. Are opioids dependent or addicted 4. Have morbid obesity (BMI > 40) 5. Have sickle cell disease, uncontrollable diabetic mellitus or other chronic medical conditions that can affect wound healing (cardiac, hepatic or renal insufficiency) 6. Eventually have recourse to General anaesthesia for any reason. 7. Eventually have complications during surgery such as postpartum haemorrhage, major injury to visceral structures, intrauterine foetal death, major congenital malformation or neonatal intensive care unit admission within first 24 hours of life. Adult: 19 Year-44 Year 19 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 19/02/2024 UNIVERSITY OF ILORIN TEACHING HOSPITAL ETHICS RESEARCH COMMITTEE
Ethics Committee Address
Street address City Postal code Country
OLD JEBBA ROAD,OKE OSE,ILORIN ILORIN 251105 Nigeria
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 19/02/2024 UNIVERSITY OF ILORIN TEACHING HOSPITAL ETHICAL REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
OLD JEBBA ROAD,OKE OSE,ILORIN ilorin 251105 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time of first analgesic request in the groups. [Time of first analgesic request defined as time interval after completion of caesarean section (end of skin closure) to time patient first request for analgesic.] After caesarean section
Secondary Outcome (a) Maternal static and dynamic pain scores using NRS at 0 hour (30 minutes after surgery), 2 hours,4 hours,6 hours,8 hours, 12hours, and 24hours (b) The total amount of rescue analgesia consumed over the 24 hour duration. will be calculated by adding the total rescue analgesia administered to the patients over the 24 hour period. (c) Time from surgery to mobility – time frame from end of surgery to ambulation. Participants will be requested to make an attempt to move out of bed 7 hours post operatively when the effect of spinal block would have stopped, then 2 hourly thereafter. The time of first successful attempt shall be recorded. (d) Time from surgery to breastfeeding: participants will be asked during the 24hrs duration for the convenience of breast feeding unaided 4 hours after surgery, then 2hourly till she can breastfeed by herself. if she is able to do so, the time of first attempt at breast feeding is recorded. For those that may not be able to breastfeed due to events like neonatal intensive care unit (NICU) admission shall be excluded from the study. Most times, need for NICU admission will be known before skin closure. (e) Maternal-to-neonate attachment satisfaction: participants will be allowed to carry their babies as frequent as they desire after surgery. Their satisfaction about the attachment will be scored using 5 point likert scale as very satisfied, satisfied, undecided, dissatisfied and very dissatisfied (f) Surgical site wound hematoma: Postoperative surgical site hematoma at 24 hours wound check (g) Side effects: evaluation and documentation will be taken (h) Cost analysis between the groups (i). Patient satisfaction with analgesia: The patients will be asked about their satisfaction with analgesia and their assessment recorded. The 5 point likert scale will be used where satisfaction will be assessed as very satisfied, satisfied, undecided, dissatisfied and very dissatisfied post caesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KWARA STATE TEACHING HOSPITALILORIN ABDUL AZEEZ ATTAH ROAD,ILORIN ILORIN Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdullahi musa olatunji airport road,ilorin ilorin 240241 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor abdullahi musa olatunji airport road ilorin ilorin 240241 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Musa Abdullahi tunjimusa82@gmail.com +2348035494785 Airport road ilorin
City Postal code Country Position/Affiliation
ilorin 240243 Nigeria principal investigator
Role Name Email Phone Street address
Public Enquiries IDOWU OGUNLAJA OGUNLAJAIDOWU@YAHOO.COM +2347035932939 KWARA STATE TEACHING HOSPITAL ILORIN
City Postal code Country Position/Affiliation
ILORIN 240242 Nigeria SUPERVISOR
Role Name Email Phone Street address
Scientific Enquiries ISRAEL KOLAWOLE kolawole.israel@gmail.com +2348033781032 university of ilorin teaching hospital,ilorin
City Postal code Country Position/Affiliation
ilorin 240102 Nigeria supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification, will be shared, including the study protocol, statistical analysis plan, informed consent form, and analytic code. The data will be available after 12 months of publication and will end after seven years of publication. The data will be shared with researchers who have ethical approval for the proposed study; the study methodology is sound; it is meant for individual meta-analysis; and the data requestor has signed a data access agreement. The proposal should be directed to tunjimusa82@gmail.com. The data will be available for six years. Analytic Code,Clinical Study Report 1 YEAR TUNJI
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