PostpartumPhase 3NCT03146000
Lidocaine-prilocaine Cream Versus Rectal Meloxicam on Relief of Post-episiotomy Pain
A Phase 3 study testing lidocaine-prilocaine cream and meloxicam rectal suppository in people with Postpartum, run by Assiut University at 1 site in Egypt.
Trial summary
Postpartum perineal pain is a very common complaint. It can have negative consequences for mother and child including disability in daily functioning for the mother; for example, it can interfere in taking care of her infant and in breastfeeding. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum
- What is being tested?
- lidocaine-prilocaine cream and meloxicam rectal suppository
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2017to 1 Oct 2018
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primiparas
- Normal vaginal delivery
- Mediolateral episiotomy
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patients who had postpartum hemorrhage
- Patients who had manual removal of the placenta
- Patients with contraindications to non steroidal drugs
- Patients with a multiple perineal lacerations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Lidocaine-prilocaine Cream Versus Rectal Meloxicam Suppository on Relief of Post-episiotomy Pain: A Randomized Clinical Trial
Postpartum perineal pain is a very common complaint. It can have negative consequences for mother and child including disability in daily functioning for the mother; for example, it can interfere in taking care of her infant and in breastfeeding. Early pain management is thus relevant to provide relief and prevent chronicity.
Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the first day after birth, of 75% in women with an intact perineum
- Conditions
- Postpartum
- Being tested
- lidocaine-prilocaine cream, meloxicam rectal suppository
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine-prilocaine creamDrug
topical cream
meloxicam rectal suppositoryDrug
suppository
| Study group | Role | What they receive |
|---|---|---|
| lidocaine-prilocaine | Experimental | women will receive 5 mg lidocaine-prilocaine cream topically on the episiotomy line Receives: Drug: lidocaine-prilocaine cream |
| meloxicam | Active comparator | women will receive one 15 mg meloxicam rectal suppository Receives: Drug: meloxicam rectal suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference of visual analog scale after delivery
the scale is graded from 0 to 10
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 May 2017
- Primary completion31 Aug 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146000
- Sponsor's protocol ID
- PEP
- Status last verified
- Aug 2019
- First submitted
- 5 May 2017
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- 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 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Lidocaine-prilocaine Cream Versus Rectal Meloxicam Suppository on Relief of Post-episiotomy Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03146000
- Acronym / sponsor ID
- PEP
- Conditions
- Postpartum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 9 May 2017 (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.
Postpartum perineal pain is a very common complaint. It can have negative consequences for mother and child including disability in daily functioning for the mother; for example, it can interfere in taking care of her infant and in breastfeeding. Early pain management is thus relevant to provide relief and prevent chronicity.
Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the first day after birth, of 75% in women with an intact perineum
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine-prilocaine | Experimental | Drug: lidocaine-prilocaine creamwomen will receive 5 mg lidocaine-prilocaine cream topically on the episiotomy line |
| meloxicam | Active comparator | Drug: meloxicam rectal suppositorywomen will receive one 15 mg meloxicam rectal suppository |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Primiparas
- Normal vaginal delivery
- Mediolateral episiotomy
- Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (4 listed)
- Patients who had postpartum hemorrhage
- Patients who had manual removal of the placenta
- Patients with contraindications to non steroidal drugs
- Patients with a multiple perineal lacerations
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 |
|---|---|---|
| lidocaine-prilocaine creamtopical cream | Drug | lidocaine-prilocaine |
| meloxicam rectal suppositorysuppository | Drug | meloxicam |
Primary outcome
The mean difference of visual analog scale after delivery
Time frame: immediately
the scale is graded from 0 to 10
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 19 Aug 2019.
- Individual participant dataSharing planned: No
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lidocaine-prilocaine cream and meloxicam rectal suppository in people with Postpartum, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 4 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 19 Aug 2019. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The mean difference of visual analog scale after delivery (time frame: immediately). 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 19 Aug 2019.