Clinical trial NCT06845930: Rectal Versus Intramuscular Diclofenac for Pain Relief Following Caesarean Section
Official title: Rectal Versus Intramuscular Diclofenac for Pain Relief Following Elective Caesarean Section at Alex Ekwueme Federal University Teaching Hospital Abakaliki: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Painrelief
Postoperative
Keywords: Rectal diclofenac
Caesarean section
Lead sponsor: Federal Teaching Hospital Abakaliki
Sponsor class: OTHER_GOV
First posted: 2025-02-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.

Detailed description: Background: Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.

Aim: This study is designed to compare the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital, Abakaliki.

Methods: This was a randomized equivalence controlled trial conducted among pregnant women booked for elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital Abakaliki, comparing the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective caesarean section at term. One arm received 100mg of suppository diclofenac and the other arm received 75mg of intramuscular diclofenac. These doses were repeated every 12hours for 24 hours. Pain scoring was done at 1, 6, 12, 18 and 24 hours after administration of the drugs. The data obtained was analysed using IBM SPSS software (version 23, Chicago II, USA) and the intention to treat concept. A difference with a P value of ≤ 0.05 was taken to be statistically significant.

Eligibility criteria: Inclusion Criteria:

* Elective caesarean section at term with spinal anaesthesia;E

Exclusion Criteria:

1. Allergy to NSAIDS
2. Bleeding diathesis
3. Use of general anesthesia
4. Chronic liver disease
5. History of renal disease
6. Asthma in pregnancy
7. Emergency Cesarean section
8. Morbid obesity
9. Sickle cell anaemia patients
10. Hypertensive disorders of pregnancy
11. Refusal to give consent

Primary outcomes:
measure: Pain score after the administration of the rectal and intramuscular diclofenac
timeFrame: 24 hours after the last dose
Secondary outcomes:
measure: maternal side effects and need for additional analgesia
timeFrame: 24 hours after the last dose
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: Alex Ekwueme Federal University Teaching Hospital
state: Ebonyi
Study officials:
References: