Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

Assiut University

Status: Unknown

Conditions: Episiotomy Wound

Treatments: Drug: Diclofenac Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT04331210

Post episiotomy analgesia

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,024 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,024 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Using diclofenac sodium suppository 50 mg immediately after suturing and then every 8 hours

Treatment:

Drug: Diclofenac Sodium

Group 2

Active Comparator group

Description:

Using diclofenac sodium tablets 50 mg every 8 hours after birth

Treatment:

Drug: Diclofenac Sodium