Rectal Versus Intramuscular Diclofenac for Pain Relief Following Caesarean Section

Not Applicable

Completed

• Conditions: Painrelief; Postoperative
• Interventions: Drug: Rectal Diclofenac; Drug: Intramuscular diclofenac

• Registration Number: NCT06845930
• Lead Sponsor: Assumpta Nnenna Nweke

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.

Study Timeline

• Study Start: 2021-04-19
• Primary Completion: 2021-09-18
• Study Completion: 2021-09-18
• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectal diclofenac	Rectal Diclofenac	Participants had 100mg of rectal diclofenac administered immediately after skin closure by the researcher. The medication was repeated every 12hourly for 24 hours. For all the participants, 30 mg pentazocine was given intramuscularly every 6 hours for 24 hours.
Intramuscular diclofenac	Intramuscular diclofenac	Participants had 75mg of intramuscular diclofenac administered immediately after skin closure by the researcher. The medication was repeated every 12hourly for 24 hours. For all the participants, 30 mg pentazocine was given intramuscularly every 6 hours for 24 hours.

Primary Outcome Measures

Name	Time	Method
Pain score after the administration of the rectal and intramuscular diclofenac	24 hours after the last dose	Pain score at different intervals with either rectal or intramuscular diclofenac immediately after skin closure. This pain assessment was done with visual analogue scale ranging from 0 to 10. zero represents no pai while ten represents the worst possible pain.

Secondary Outcome Measures

Name	Time	Method
maternal side effects and need for additional analgesia	24 hours after the last dose	Number of participants with local irritation at the site of injection or insertion of drug,headache,dizziness and loss of appetite. a Also the number of participants requiring additional analgesia

Trial Locations

Locations (1)

Alex Ekwueme Federal University Teaching Hospital; 🇳🇬 Abakaliki, Ebonyi, Nigeria