Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04331210
• Collaborator: (none)
• Enrollment: 1,024
• Arms: 2
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Episiotomy Wound	Drug: Diclofenac Sodium	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1024 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain
• Anticipated Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

• Study Chair: Diaa eldin Mohammed, Professor, women health hospital assiut university
• Study Director: Osama Saber, Lecturer, women health hospital assiut university

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Worldwide website written collaporatively by people who use it
• a free search engine accessing primarily the MEDLINE database of references and abstracts on life sciences and biomedical topics

Publications

None provided.

• Responsible Party: Mohammed Hosny Ahmed, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04331210
• Other Study ID Numbers: Post episiotomy analgesia
• First Posted: Apr 2, 2020
• Last Update Posted: Apr 2, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohammed Hosny Ahmed, Principal investigator, Assiut University: Episiotomy
• Additional relevant MeSH terms: Diclofenac

Study Results

No Results Posted as of Apr 2, 2020