Post Operative PainNCT07050615
Comparison of the Frequency of Post-Operative Pain of Continuous Versus Interrupted Suturing Techniques in Episiotomy
A study testing Continuous suturing and Interrupted suturing in people with Post Operative Pain, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
Post-operative pain is the most prevalent issue following an episiotomy, greatly affecting patients both physically and mentally, resulting in increased morbidity. This study seeks to compare the effectiveness of continuous and interrupted suturing techniques for episiotomy post-operative pain among the local… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Continuous suturing and Interrupted suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 31 Jan 2025
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant females
- Aged 20-40years
- Undergoing an episiotomy to facilitate the delivery of the head in the labor room
- First or second pregnancy
- Gestational age of 37-41+6 weeks
Who cannot join
- Females, undergone an instrumental vaginal delivery
- With a history of previous perineal surgery
- With high-risk pregnancies (those having hypertension, anemia or bleeding tendency, diabetes mellitus, a suspected genital infection)
- With impaired immunity
- Taking corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Frequency of Post-operative Pain of Continuous Versus Interrupted Suturing Technique in Episiotomy
Post-operative pain is the most prevalent issue following an episiotomy, greatly affecting patients both physically and mentally, resulting in increased morbidity. This study seeks to compare the effectiveness of continuous and interrupted suturing techniques for episiotomy post-operative pain among the local population.
Read the detailed description
There is a lack of recent local data regarding the management of post-operative pain using different suturing techniques. The findings of this study would help in adopting a more effective technique, resulting in reducing the postoperative pain and lowering morbidity. Practical recommendations can be made to enhance routine practices and establish guidelines for these patients.
- Conditions
- Post Operative Pain
- Being tested
- Continuous suturing, Interrupted suturing
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous suturingProcedure or surgery
In this group, episiotomy repair was done using the continuous suturing.
Interrupted suturingProcedure or surgery
In this group, episiotomy repair was done using the interrupted suturing.
| Study group | Role | What they receive |
|---|---|---|
| Continuous group | Experimental | In this group patients under going episiotomy, went through continuous suturing Receives: Procedure: Continuous suturing |
| Interrupted group | Experimental | In this group patients under going episiotomy, went through interrupted suturing Receives: Procedure: Interrupted suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Post-operative pain (yes/no) was noted using the visual analogue scale (VAS).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Aug 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arooj Akram, Principal investigator, Shahida Islam Medical Complex, LodhranJoveria Sadaf, Principal investigator, Shahida Islam Medical Complex, Lodhran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050615
- Sponsor's protocol ID
- DRAROOJ-SITH
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Frequency of Post-operative Pain of Continuous Versus Interrupted Suturing Technique in Episiotomy
- ClinicalTrials.gov ID
- NCT07050615
- Acronym / sponsor ID
- DRAROOJ-SITH
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 3 Jul 2025 (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.
Post-operative pain is the most prevalent issue following an episiotomy, greatly affecting patients both physically and mentally, resulting in increased morbidity. This study seeks to compare the effectiveness of continuous and interrupted suturing techniques for episiotomy post-operative pain among the local population.
Detailed description
There is a lack of recent local data regarding the management of post-operative pain using different suturing techniques. The findings of this study would help in adopting a more effective technique, resulting in reducing the postoperative pain and lowering morbidity. Practical recommendations can be made to enhance routine practices and establish guidelines for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous group | Experimental | Procedure: Continuous suturingIn this group patients under going episiotomy, went through continuous suturing |
| Interrupted group | Experimental | Procedure: Interrupted suturingIn this group patients under going episiotomy, went through interrupted suturing |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant females
- Aged 20-40years
- Undergoing an episiotomy to facilitate the delivery of the head in the labor room
- First or second pregnancy
- Gestational age of 37-41+6 weeks
Key exclusion criteria (5 listed)
- Females, undergone an instrumental vaginal delivery
- With a history of previous perineal surgery
- With high-risk pregnancies (those having hypertension, anemia or bleeding tendency, diabetes mellitus, a suspected genital infection)
- With impaired immunity
- Taking corticosteroids
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 |
|---|---|---|
| Continuous suturingIn this group, episiotomy repair was done using the continuous suturing. | Procedure or surgery | Continuous group |
| Interrupted suturingIn this group, episiotomy repair was done using the interrupted suturing. | Procedure or surgery | Interrupted group |
Primary outcome
Post operative pain
Time frame: 48 hours
Post-operative pain (yes/no) was noted using the visual analogue scale (VAS).
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 3 Jul 2025.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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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.
Arooj Akram principal investigator
Shahida Islam Medical Complex, Lodhran
Joveria Sadaf principal investigator
Shahida Islam Medical Complex, Lodhran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous suturing and Interrupted suturing in people with Post Operative Pain, run by RESnTEC, Institute of Research at 1 site in Pakistan.
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 5 inclusion and 5 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
Post operative pain (time frame: 48 hours). 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 3 Jul 2025.