Painrelief, Postoperative
Conditions
Keywords
Rectal diclofenac, Caesarean section
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.
Interventions
Rectal diclofenac, 100mg administered immediately after skin closure then 12 hourly for 24 hours.
Intramuscular diclofenac, 7mg administered immediately after skin closure then 12 hourly for 24 hours.
Sponsors
Assumpta Nnenna Nweke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
open label randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Nigeria
Outcome results
None listed