Improving Quality of LifePhase 4LPPTNCT02883179
Pain Relief During Repair of Postpartum Perineal Tears
A Phase 4 study testing lidocaine injection and lidocaine-prilocaine cream in people with Improving Quality of Life, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal tears. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Improving Quality of Life
- What is being tested?
- lidocaine injection and lidocaine-prilocaine cream
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Sep 2017
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestational age > 37 weeks
- Uncomplicated pregnancy
- Single vertex fetus
- Normal vaginal delivery
- Women who will accept to participate in the study
Who cannot join
- Women received epidural analgesia
- Women required episiotomy
- Women with intact perineum
- Operative vaginal delivery
- Allergy to the used drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Lidocaine-prilocaine Cream Versus Lidocaine Infiltration for Pain Relief During Repair of Postpartum Perineal Tears: A Randomized Controlled Trial
The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal tears.
- Conditions
- Improving Quality of Life
- Being tested
- lidocaine injection, lidocaine-prilocaine cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine injectionDrug
Also called depocaine
anhydrous solution
lidocaine-prilocaine creamDrug
Also called pridocaine
topical cream
| Study group | Role | What they receive |
|---|---|---|
| lidocaine injection | Active comparator | 5 mL of 2% lidocaine anhydrous solution (Depocaine) will be injected slowly along the lines of the edges of the perineal tears after delivery, with frequent aspirations to avoid intravascular injection. Receives: Drug: lidocaine injection |
| lidocaine-prilocaine cream | Experimental | 5-g dose of Lidocaine-prilocaine cream will be applied to the intact tissue around each tear for 5 minutes before suturing Receives: Drug: lidocaine-prilocaine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score during suture of perineal tears
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Quality of LifeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 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
- NCT02883179
- Sponsor's protocol ID
- LPPT
- Acronym
- LPPT
- Status last verified
- Dec 2017
- First submitted
- 22 Aug 2016
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Lidocaine-prilocaine Cream Versus Lidocaine Infiltration for Pain Relief During Repair of Postpartum Perineal Tears: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02883179
- Acronym / sponsor ID
- LPPT / LPPT
- Conditions
- Improving Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- 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.
The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal tears.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine injection | Active comparator | Drug: lidocaine injection5 mL of 2% lidocaine anhydrous solution (Depocaine) will be injected slowly along the lines of the edges of the perineal tears after delivery, with frequent aspirations to avoid intravascular injection. |
| lidocaine-prilocaine cream | Experimental | Drug: lidocaine-prilocaine cream5-g dose of Lidocaine-prilocaine cream will be applied to the intact tissue around each tear for 5 minutes before suturing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gestational age > 37 weeks
- Uncomplicated pregnancy
- Single vertex fetus
- Normal vaginal delivery
- Women who will accept to participate in the study
Key exclusion criteria (5 listed)
- Women received epidural analgesia
- Women required episiotomy
- Women with intact perineum
- Operative vaginal delivery
- Allergy to the used drugs
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 injectionAlso: depocaineanhydrous solution | Drug | lidocaine injection |
| lidocaine-prilocaine creamAlso: pridocainetopical cream | Drug | lidocaine-prilocaine cream |
Primary outcome
Mean pain score during suture of perineal tears
Time frame: 30 minutes
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 13 Dec 2017.
- Individual participant dataSharing planned: Yes
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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 4 study testing lidocaine injection and lidocaine-prilocaine cream in people with Improving Quality of Life, 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 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 13 Dec 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean pain score during suture of perineal tears (time frame: 30 minutes). 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 13 Dec 2017.