Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

Not Applicable

• Conditions: Episiotomy Wound
• Interventions: Drug: Diclofenac Sodium

• Registration Number: NCT04331210
• Lead Sponsor: Assiut University

Brief Summary

Current study aims to compare oral diclofenac sodium with it's rectal form for analgesia of pain after episiotomy.

Detailed Description

* Episiotomy is a surgical incision of the perineum and the posterior vaginal wall.

* it can be done at a 60 degree angle from the vulva towards the anus or at an angle from the posterior end of the vulva.

* usually under local anesthetic and is sutured after delivery.

* It is done during second stage of labor to enlarge the opening for the baby to pass through to avoid soft-tissue tearing which may involve the anal sphincter and rectum.

* Perineal pain after episiotomy has immediate and long-term negative effects for women and their babies. These effects can interfere with breastfeeding and the care of the infant.

* Usually women undergo episiotomy need a good analgesic to overcome pain resulting from the analgesic.

* Previous study by Faiza shafi, Shazia sayed, Naheed bano, Rizwana chaudhri, Holy family hospital, Rawalpindi, Pakistan, The study was published in journal of Rawalpindi medical college and concluded that rectal diclofenac should be further promoted , for pain relief, in women following episiotomy.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-03-31
• Last Update Submitted: 2020-03-31
• Study First Posted: 2020-04-02
• Last Update Posted: 2020-04-02
• Study Start: 2020-09-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1024

Inclusion Criteria

1. age: 20:35 years.
2. Primigravidae as elective procedure.
3. face to pubis delivery.
4. Big baby.
5. Narrow pelvic arch.
6. Elderly primigravida.
7. old perineal scar as episiotomy or perineorrhaphy.
8. Manipulative delivery.
9. To cut short second stage cases such as pre eclampsia.
10. Premature baby.
11. Fetal distress.

Exclusion Criteria

1. more than 35 years.
2. pelvic inflammatory disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Diclofenac Sodium	Using diclofenac sodium suppository 50 mg immediately after suturing and then every 8 hours
Group 2	Diclofenac Sodium	Using diclofenac sodium tablets 50 mg every 8 hours after birth

Primary Outcome Measures

Name	Time	Method
Post episiotomy pain relief	First three days after delivery	The relief of pain after delivery measured by pain relief scale..Pain relief scale Title: pain intensity scale Minimum 0 means no pain Maximum 4 means severe pain