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Completed

NCT Number: NCT06845930

Rectal Versus Intramuscular Diclofenac for Pain Relief Following Caesarean Section

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.

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Key information

Conditions

Painrelief Postoperative

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective caesarean section at term with spinal anaesthesia;E

Exclusion criteria

  • Allergy to NSAIDS
  • Bleeding diathesis
  • Use of general anesthesia
  • Chronic liver disease
  • History of renal disease
  • Asthma in pregnancy
  • Emergency Cesarean section
  • Morbid obesity
  • Sickle cell anaemia patients
  • Hypertensive disorders of pregnancy
  • Refusal to give consent

Treatment and study plan

Rectal Diclofenac

Drug

Rectal diclofenac, 100mg administered immediately after skin closure then 12 hourly for 24 hours.

Intramuscular diclofenac

Drug

Intramuscular diclofenac, 7mg administered immediately after skin closure then 12 hourly for 24 hours.

Primary outcomes

  1. Pain score after the administration of the rectal and intramuscular diclofenac

    Time frame: 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 outcomes

  1. maternal side effects and need for additional analgesia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assumpta Nnenna Nweke

Other Gov

Registry information

Official study title

Rectal Versus Intramuscular Diclofenac for Pain Relief Following Elective Caesarean Section at Alex Ekwueme Federal University Teaching Hospital Abakaliki: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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