Episiotomy PainPhase 4NCT03264586
The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies
A Phase 4 study testing Lidocaine-prilocaine cream, mepivacaine infiltration group and mediolateral episiotomy in people with Episiotomy Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Included women were divided randomly into two groups: Group A: (n=100): women were subjected to application of EMLA® cream "Lidocaine-prilocaine cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)"for pain relief during episiotomy repair. Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Episiotomy Pain
- What is being tested?
- Lidocaine-prilocaine cream, mepivacaine infiltration group and mediolateral episiotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2017to Mar 2018
- 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 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age 37 weeks or more
- Singleton gestation.
- Uncomplicated pregnancy.
- Vertex presentation.
Who cannot join
- Epidural analgesia request.
- Operative delivery.
- No other methods are used for pain control 2hours befor episiotomy
- Previous adverse reaction to local anesthetic.
Trial locations and contacts
1 site in 1 country.
Ahmed Abd ElHak, MD contact
About this study
Official title: The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies: A Randomized Clinical Trial
Included women were divided randomly into two groups:
Group A: (n=100): women were subjected to application of EMLA® cream "Lidocaine-prilocaine cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)"for pain relief during episiotomy repair.
Group B: (n=100): women were subjected to application of local injection of 10 ml of 1% mepivacaine for pain relief during episiotomy repair.
Read the detailed description
During the second stage of labor, women were placed in the lithotomy position. 10- Patients who were enrolled in the study were guaranteed to obtain additional anesthesia during episiotomy repair whenever pain exceeded the tolerability threshold.
11- Volunteers were assigned randomly to have either local injection of 10 ml of 1% mepivacaine or application of 5gm-dose® EMLA cream"Lidocaine- prilocaine cream(EMLA cream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)" for pain relief during episiotomy repair.
- Group A: "EMLA group"
- Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum
- EMLA cream was applied, 1 hour before the expected time of birth.
- With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation.
- No additional anesthetic was applied if episiotomy was necessary.
- Before commancement of perineal repair any residual cream was wiped off.
- Group B: "mepivacaine infiltration group".
- In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
- In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
- The suture procedure was delayed 10 minutes after the injection of the aneathetic
- All episiotomies were performed at the top of contraction as mediolateral episiotomies. 12- Episiotomy repair
- In all cases episiotomies was repaired with a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0).
- The suture begins about 0.5 cms above the apex of the vaginal wound The suture are evenly placed to allow for approximation of the edges of the wound without causing tension or wrinkling or over lapping.
- At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound to restore the appearance of the hymenal ring, the fourchette and the beginning of the perineal skin.
- At the point where perineal skin begins; the suture is then passed beneath the vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is closed first, ensuring no dead space one left behind, and ensuring no bleeding points are ignored.
- The skin was closed with the same continuous suture to approximate the subcutinuous tissue.
- The wound is cleared with antiseptic solution and covered by addressing. 14- Before leaving the delivery suite (approximately 2 hours after delivery) each patient was asked to record the severity of pain that she had experienced during perineal repair in a 10-cm visual analog scale, where 0 cm means no pain and 10 cm means unbearable pain.
- The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale
- Finally, women were asked to express their overall satisfaction with the anesthesia method during perineal repair with "yes" or "no" answers
- Conditions
- Episiotomy Pain
- Being tested
- Lidocaine-prilocaine cream, mepivacaine infiltration group, mediolateral episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine-prilocaine creamDrug
Also called EMLA cream
5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate penetration
- EMLA cream was applied, 1 hour before the expected time of birth.
mepivacaine infiltration groupDrug
Also called 1% mepivacaine
10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
- In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
- The suture procedure was delayed 10 minutes after the injection of the aneathetic
mediolateral episiotomyProcedure or surgery
Episiotomy repair a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0).
- At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound
- At the point where perineal skin begins; the suture is then passed beneath the vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is closed first, ensuring no dead space one left behind
- The skin was closed with the same continuous suture to approximate the subcutinuous tissue.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine-prilocaine cream | Active comparator | Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum
* EMLA cream was applied, 1 hour before the expected time of birth.
* With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation.
* No additional anesthetic was applied if episiotomy was necessary.
* Before commancement of perineal repair any residual cream was wiped off. Receives: Drug: Lidocaine-prilocaine cream; Procedure: mediolateral episiotomy |
| mepivacaine infiltration group | Active comparator | * In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
* In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
* The suture procedure was delayed 10 minutes after the injection of the aneathetic Receives: Drug: mepivacaine infiltration group; Procedure: mediolateral episiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study startAug 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264586
- Sponsor's protocol ID
- 9
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03264586
- Acronym / sponsor ID
- 9
- Conditions
- Episiotomy Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 29 Aug 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.
Included women were divided randomly into two groups:
Group A: (n=100): women were subjected to application of EMLA® cream "Lidocaine-prilocaine cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)"for pain relief during episiotomy repair.
Group B: (n=100): women were subjected to application of local injection of 10 ml of 1% mepivacaine for pain relief during episiotomy repair.
Detailed description
During the second stage of labor, women were placed in the lithotomy position. 10- Patients who were enrolled in the study were guaranteed to obtain additional anesthesia during episiotomy repair whenever pain exceeded the tolerability threshold.
11- Volunteers were assigned randomly to have either local injection of 10 ml of 1% mepivacaine or application of 5gm-dose® EMLA cream"Lidocaine- prilocaine cream(EMLA cream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)" for pain relief during episiotomy repair.
- Group A: "EMLA group"
- Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum
- EMLA cream was applied, 1 hour before the expected time of birth.
- With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation.
- No additional anesthetic was applied if episiotomy was necessary.
- Before commancement of perineal repair any residual cream was wiped off.
- Group B: "mepivacaine infiltration group".
- In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
- In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
- The suture procedure was delayed 10 minutes after the injection of the aneathetic
- All episiotomies were performed at the top of contraction as mediolateral episiotomies. 12- Episiotomy repair
- In all cases episiotomies was repaired with a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0).
- The suture begins about 0.5 cms above the apex of the vaginal wound The suture are evenly placed to allow for approximation of the edges of the wound without causing tension or wrinkling or over lapping.
- At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound to restore the appearance of the hymenal ring, the fourchette and the beginning of the perineal skin.
- At the point where perineal skin begins; the suture is then passed beneath the vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is closed first, ensuring no dead space one left behind, and ensuring no bleeding points are ignored.
- The skin was closed with the same continuous suture to approximate the subcutinuous tissue.
- The wound is cleared with antiseptic solution and covered by addressing. 14- Before leaving the delivery suite (approximately 2 hours after delivery) each patient was asked to record the severity of pain that she had experienced during perineal repair in a 10-cm visual analog scale, where 0 cm means no pain and 10 cm means unbearable pain.
- The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale
- Finally, women were asked to express their overall satisfaction with the anesthesia method during perineal repair with "yes" or "no" answers
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine-prilocaine cream | Active comparator | Drug: Lidocaine-prilocaine cream, Procedure: mediolateral episiotomyWomen who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum * EMLA cream was applied, 1 hour before the expected time of birth. * With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation. * No additional anesthetic was applied if episiotomy was necessary. * Before commancement of perineal repair any residual cream was wiped off. |
| mepivacaine infiltration group | Active comparator | Drug: mepivacaine infiltration group, Procedure: mediolateral episiotomy* In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection. * In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution. * The suture procedure was delayed 10 minutes after the injection of the aneathetic |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gestational age 37 weeks or more
- Singleton gestation.
- Uncomplicated pregnancy.
- Vertex presentation.
Key exclusion criteria (4 listed)
- Epidural analgesia request.
- Operative delivery.
- No other methods are used for pain control 2hours befor episiotomy
- Previous adverse reaction to local anesthetic.
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 creamAlso: EMLA cream5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate penetration - EMLA cream was applied, 1 hour before the expected time of birth. | Drug | Lidocaine-prilocaine cream |
| mepivacaine infiltration groupAlso: 1% mepivacaine10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection. * In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution. * The suture procedure was delayed 10 minutes after the injection of the aneathetic | Drug | mepivacaine infiltration group |
| mediolateral episiotomyEpisiotomy repair a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0). * At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound * At the point where perineal skin begins; the suture is then passed beneath the vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is closed first, ensuring no dead space one left behind * The skin was closed with the same continuous suture to approximate the subcutinuous tissue. | Procedure or surgery | Lidocaine-prilocaine cream, mepivacaine infiltration group |
Primary outcome
pain
Time frame: 24 hours after delivery
The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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.
Ahmed Abd ElHak, MD contact
Ahmed Maged, MD principal investigator
kasr Alainy medical school
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-prilocaine cream, mepivacaine infiltration group and mediolateral episiotomy in people with Episiotomy Pain, run by Cairo 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: status not confirmed, as of the sponsor's last update on 29 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 24 hours after delivery). 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 29 Aug 2017.