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Randomised Controlled Study Of The Effectiveness Of Wound Infiltration With Bupivacaine in Post Caesarean Section Analgesia In Kwara State Teaching Hospital, Ilorin

Randomised Controlled Study Of The Effectiveness Of Wound Infiltration With Bupivacaine in Post Caesarean Section Analgesia In Kwara State Teaching Hospital, Ilorin

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202404745779132
Enrollment
108
Registered
2024-04-08
Start date
2023-10-20
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth

Interventions

Bupivacaine infiltration on the subcutaneous layer group
GROUP B
Group C

Sponsors

abdullahi musa olatunji
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All consenting pregnant women for elective or emergency caesarean section with live fetuses under subarachnoid block (regardless of numbers of previous caesarean delivery).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.]

Secondary

MeasureTime frame
(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, dissatisfie

Countries

Nigeria

Contacts

Public ContactIDOWU OGUNLAJA

SUPERVISOR

OGUNLAJAIDOWU@YAHOO.COM+2347035932939

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026