Efficacy of Single Dose Rectal Diclofenac With Oral Diclofenac for the Relief of Perineal Pain Within 24 Hours After Episiotomy

NCT ID: NCT06220279

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-12-31

Brief Summary

Episiotomy is the commonest surgical procedure performed on parturient. It is usually associated with perineal pain which is particularly severe in the first 24 hours post repair. Perineal pain after episiorrhaphy if not adequately managed puts the woman into painful distress thus preventing good immediate post-partum care for the newborn. The aim is to compare the efficacy of single dose rectal diclofenac with oral diclofenac for the relief of perineal pain within 24 hours after episiotomy repair at Alex Ekwueme Federal University Teaching Hospital Abakaliki.

Detailed Description

Episiotomy is the commonest surgical procedure performed on parturient. It is usually associated with perineal pain which is particularly severe in the first 24 hours post repair. Perineal pain after episiorrhaphy if not adequately managed puts the woman into painful distress thus preventing good immediate post-partum care for the newborn.

Aim: To compare the efficacy of single dose rectal diclofenac with oral diclofenac for the relief of perineal pain within 24 hours after episiotomy repair at Alex Ekwueme Federal University Teaching Hospital Abakaliki.

Materials and Methods: This was a randomized controlled trial that involved 146 women that had episiorrhaphy between June and December 2020. The women were randomized into two groups of 73 women each using computer generated random numbers. One group received 100mg of diclofenac suppository stat while the other group received 2 doses of 50mg of oral diclofenac 12 hours apart, both for 24 hours after episiorrhaphy. Pain was assessed at 1, 4, 8, 16 and 24 hours post episiorraphy using a Visual Analogue Scale. Maternal satisfaction for the mode of the pain relief was assessed using the Likert scale after 24 hours. Data obtained was analyzed using Statistical Package for Social Science software version 25.

The perineal pain was categorized into: no pain (0cm), mild (1-3cm), moderate (4-7cm) and severe (8-10cm), while maternal satisfaction was categorized into: Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied. Categorical variables were summarized using frequencies and proportion. Quantitative variables were summarized with means and standard deviation. Student t-test was used for comparison between the group means for continuous variables while Chi-squared test was used to compare categorical variables. Statistical significance was obtained when p-value was ≤ 0.05.

Conditions

Pain Relief After Episiotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1, oral diclofenac

Two doses of 50mg oral diclofenac 12 hours apart was administered to this arm

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

Each were monitored for pain within 24 hours

Arm 2, rectal diclofenac

100mg diclofenac was administered rectally to this arm

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

Each were monitored for pain within 24 hours

Interventions

Diclofenac

Each were monitored for pain within 24 hours

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Uncomplicated pregnancy
• Gestational age of 37 weeks and above who had episiotomy
• Singleton gestation
• Vaginal delivery
• Instrumental vaginal delivery
• Consented women

Exclusion Criteria

• Women that declined consent
• Postpartum hemorrhage.
• Women who had perineal tear
• History of peptic ulcer diseases
• History of bleeding coagulopathies
• Adverse reaction or hypersensitivity to diclofenac
• Any woman with special postpartum pain relief plan such as sickle cell disease patient
• Preeclamptic/eclamptic, renal and liver diseases patients.
• Parturient on epidural anesthesia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal Teaching Hospital Abakaliki

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nwali Matthew Igwe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, Nigeria

Federal Teaching Hospital, Abakaliki

Abakaliki, Ebonyi State, Nigeria

Countries

Nigeria

Other Identifiers

PRAEP2023CT

Identifier Type: -

Identifier Source: org_study_id