Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

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

Study Overview

• Status: Unknown
• Conditions: Episiotomy Wound
• Intervention / Treatment: Drug: Diclofenac Sodium

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 Type: Interventional
• Enrollment (Anticipated): 1024
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed Hosny, Physician; Phone Number: 01140762577; Email: Elto3my@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Diaa eldin Mohammed, Professor, women health hospital assiut university; Study Director: Osama Saber, Lecturer, women health hospital assiut university

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Episiotomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: Post episiotomy analgesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Iidentify individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Will be available for sharing within 6 month of completion of the study
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel.requestorswill be required to sign a data access agreement
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No