Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

Episiotomy Wound Clinical Trial

Official title:

Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04331210
• Other study ID #: Post episiotomy analgesia
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: Mohammed Hosny, Physician
• Phone: 01140762577
• Email: Elto3my[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1024
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Episiotomy Wound

Intervention

Drug:
• Diclofenac Sodium
Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post episiotomy pain relief	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	First three days after delivery

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