Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

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

Detailed Description
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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.

Official Title
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Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

Conditions
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Episiotomy Wound

Intervention / Treatment
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* Drug: Diclofenac Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 20:35 years. Primigravidae as elective procedure. face to pubis delivery. Big baby. Narrow pelvic arch. Elderly primigravida. old perineal scar as episiotomy or perineorrhaphy. Manipulative delivery. To cut short second stage cases such as pre eclampsia. Premature baby. Fetal distress. Exclusion Criteria: more than 35 years. pelvic inflammatory disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Using diclofenac sodium suppository 50 mg immediately after suturing and then every 8 hours | Drug: Diclofenac Sodium<br>* Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic<br>|
| Active Comparator: Group 2<br>Using diclofenac sodium tablets 50 mg every 8 hours after birth | Drug: Diclofenac Sodium<br>* Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Episiotomy