Pain Relief After EpisiotomyNCT06220279
Efficacy of Single Dose Rectal Diclofenac With Oral Diclofenac for the Relief of Perineal Pain Within 24 Hours After Episiotomy
A study testing Diclofenac in people with Pain Relief After Episiotomy, run by Federal Teaching Hospital Abakaliki at 2 sites in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pain Relief After Episiotomy
- What is being tested?
- Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesNigeria
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Uncomplicated pregnancy
- Gestational age of 37 weeks and above who had episiotomy
- Singleton gestation
- Vaginal delivery
- Instrumental vaginal delivery
- Consented women
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites
Alex Ekwueme Federal University Teaching Hospital
Abakaliki, Ebonyi State, 480001
Federal Teaching Hospital, Abakaliki
Abakaliki, Ebonyi State, 480001
About this study
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.
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.
Read the 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
- Being tested
- Diclofenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Each were monitored for pain within 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, oral diclofenac | Active comparator | Two doses of 50mg oral diclofenac 12 hours apart was administered to this arm Receives: Drug: Diclofenac |
| Arm 2, rectal diclofenac | Active comparator | 100mg diclofenac was administered rectally to this arm Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate pain relief after drug administration
Clients satisfaction
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief After EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Teaching Hospital Abakaliki
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nwali Matthew Igwe, Federal Teaching Hospital Abakaliki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220279
- Sponsor's protocol ID
- PRAEP2023CT
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06220279
- Acronym / sponsor ID
- PRAEP2023CT
- Conditions
- Pain Relief After Episiotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1, oral diclofenac | Active comparator | Drug: DiclofenacTwo doses of 50mg oral diclofenac 12 hours apart was administered to this arm |
| Arm 2, rectal diclofenac | Active comparator | Drug: Diclofenac100mg diclofenac was administered rectally to this arm |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Uncomplicated pregnancy
- Gestational age of 37 weeks and above who had episiotomy
- Singleton gestation
- Vaginal delivery
- Instrumental vaginal delivery
Key exclusion criteria (9 listed)
- Women that declined consent
- Postpartum hemorrhage.
- Women who had perineal tear
- History of peptic ulcer diseases
- History of bleeding coagulopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiclofenacEach were monitored for pain within 24 hours | Drug | Arm 1, oral diclofenac, Arm 2, rectal diclofenac |
Primary outcome
Adequate pain relief after drug administration
Time frame: 24hours
Clients satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac in people with Pain Relief After Episiotomy, run by Federal Teaching Hospital Abakaliki at 2 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate pain relief after drug administration (time frame: 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.