Clinical trial NCT06220279: Efficacy of Single Dose Rectal Diclofenac With Oral Diclofenac for the Relief of Perineal Pain Within 24 Hours After Episiotomy
Official title: Overall Comparison of Single Dose 100mg Rectal Diclofenac With Double Doses of 20mg Twelve Hours Apart Oral Diclofenac for Pain Relief Both for 24 Hours After Episiorrhahpy, Southeast Nigeria.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Relief After Episiotomy
Lead sponsor: Federal Teaching Hospital Abakaliki
Sponsor class: OTHER_GOV
First posted: 2024-01-23
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adequate pain relief after drug administration
timeFrame: 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: Alex Ekwueme Federal University Teaching Hospital
state: Ebonyi
city: Abakaliki
country: Nigeria
facility: Federal Teaching Hospital, Abakaliki
state: Ebonyi
Study officials:
References: