Rectal Versus Intramuscular Diclofenac for Pain Relief Following Caesarean Section

NCT06845930 | Completed

• 1 other identifier: AEFUTHA/REC/VOL 3/2020/038
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Painrelief; Postoperative

Keywords

Rectal diclofenac; Caesarean section

Outcome Measures

Primary Outcomes (1)

• Pain score after the administration of the rectal and intramuscular diclofenac

  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.

  24 hours after the last dose

Secondary Outcomes (1)

• maternal side effects and need for additional analgesia

  24 hours after the last dose

Study Arms (2)

Rectal diclofenac

EXPERIMENTAL

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.

Drug: Rectal Diclofenac

Intramuscular diclofenac

ACTIVE COMPARATOR

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.

Drug: Intramuscular diclofenac

Interventions

Rectal Diclofenac DRUG

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

Rectal diclofenac

Intramuscular diclofenac DRUG

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

Intramuscular diclofenac

Eligibility Criteria

• Age: 20 Years - 39 Years
• Gender Eligibility Details: Post caesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective caesarean section at term with spinal anaesthesia;E

You may not qualify if:

• 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

Sponsors & Collaborators

• Assumpta Nnenna Nweke: lead

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: open label randomized controlled trial

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 25, 2025
• Study Start: April 19, 2021
• Primary Completion: September 18, 2021
• Study Completion: September 18, 2021
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)