Episiotomy WoundNCT05891132
Comparison Between Lidocaine Prilocaine Cream and Lidocaine Injection on Pain Control During Episiotomy.
A study testing 10 ml of lidocaine 2% and lidocaine prilocaine cream 15gm in people with Episiotomy Wound, run by Cairo University at 1 site in Egypt.
Trial summary
The present study aims to compare the effects of lidocaine-prilocaine cream and lidocaine injection on the reduction of pain while doing and repairing episiotomy, controlling the pain in the post-partum period, and reduction the risk of infection in 6 weeks post partum and dyspareunia after 6 weeks post-partum. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy Wound
- What is being tested?
- 10 ml of lidocaine 2% and lidocaine prilocaine cream 15gm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Sep 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women candidate for VD ( ASA Ⅱ )
- Primigravida
- Pregnant more than 37 weeks (Term pregnancy).
- Singleton fetus.
- Cephalic presentation.
- In first stage of labor.
Who cannot join
- More than or equal 1 previous CS and VBAC.
- Multiparous women.
- Pregnant less than 37 weeks
- Twin pregnancy.
- Not in active labor
- allergy to lignocaine
Show all 9Show fewer
- altered mental status
- request for epidural analgesia
- Hepatic impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effects of Lidocaine Prilocaine Cream and Lidocaine Injection on Reduction of Perineal Pain During Episiotomy and Perineum Repair in Vaginal Delivery: Randomized Control Trial
The present study aims to compare the effects of lidocaine-prilocaine cream and lidocaine injection on the reduction of pain while doing and repairing episiotomy, controlling the pain in the post-partum period, and reduction the risk of infection in 6 weeks post partum and dyspareunia after 6 weeks post-partum.
Read the detailed description
Population of study \& disease condition:
The study will be conducted on 60 patients that will be admitted to the labor ward in the Department of Obstetrics \& Gynecology of a tertiary care center of Cairo University from Jan/2023 to Jan/2024 on. Primigravida women with singleton live pregnancy with cephalic presentation in the first stage of labor will be included in the study after approval by the Institutional Ethical Committee and obtaining an informed consent. Those with known allergy to lignocaine, altered mental status, request for epidural analgesia and hepatic disorders will be excluded from the study. The enrolled women will be divided into two groups by simple randomization with a 1:1 allocation ratio.
The following will be done to all participants:
- Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects.
- Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP).
- Thorough Clinical Examination: general (vital signs) and full obstetric examination.
- Obstetric ultrasonography: to confirm gestational age and the eligibility of the current pregnancy to participate in the study.
This will be a randomized controlled trial, randomization will be achieved by the following: the allocation treatment will be written on cards that will be sealed in sequentially numbered envelopes. The envelopes will be opened at the time of allocation after the enrolled participants will complete all baseline assessments. Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women of Group II will have lidocaine prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum. Lidocaine prilocaine cream, an eutectic mixture, is composed of Lidocaine-25 mg, Prilocaine-25 mg, Arlactone 289 -19 mg, Carbopol-10 mg, Sodium hydroxide to make a pH of 9.6 mg and purified water to produce l gram.
Fifteen grams of this cream will be applied as a thick layer (about 2 g/ 10 cm2 area) to the intact surface of the perineum and will be covered with an occlusive dressing (Kumar et al., 2015).
In previous study done by Nirmala et al., 2013 The mean pain scores in the study were comparable for both groups, in our study we will increase the dose and the intervals of the applied cream and we will write down the results regarding pain score and side effects.
At the time of crowning, the occlusive dressing and any residue of the cream will be removed and episiotomy will be done. The request for additional anesthetic agent (10 ml of 2% lidocaine solution for both groups) will be honored and recorded for both groups. And if the patient require additional analgesia during episiotomy (VAS more than 3) we will give additional anesthetic agent (10 ml of 2% lidocaine solution. After the repair of episiotomy, each patient will be asked to grade the severity of pain during perineal repair on a Visual Analog Scale (VAS). The far left will be labeled 'No pain' and the far right will be labelled as 'worst pain possible'. The subject will be asked to make a vertical mark on this line reflecting the severity of the pain.
The patients are followed 6 weeks post-partum at the OPC or by telephone call to check the pain score by using CAST score (Very satisfied - satisfied - not satisfied - dissatisfied).
Post-operative analgesics will include Paracetamol mainly and adjuvant NSAIDs as mentioned in the step ladder pain management by the WHO.
If any further analgesia needed we will use Pethidine as a rescue analgesic as it is safe after delivery but we will prescribe anti emetic with pethidine as it will induce nausea and vomiting.
Pain score during episiotomy repair will be the primary outcome of the study. Secondary outcome measures will include pain score in the first six weeks post-partum, dyspareunia after 6 weeks post-partum ( return to sexual life ) and reduction of the rate of wound infection.
Study location:
Kasr Al Ainy - Causality department (Department 10).
what does research involve? Human participants
Type of consent of study participants:
Written consent
Confidentiality of data:
- All study-related information will be stored at the study site.
Type of the study:
- Randomized Control Trial (RCT)
- Conditions
- Episiotomy Wound
- Being tested
- 10 ml of lidocaine 2%, lidocaine prilocaine cream 15gm
- Keywords
- Episiotomy, Anesthesia during labor, Injectable anesthetic, Topical anesthetic, Postpartum pain, Postpartum infection, Dyspareunia
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 ml of lidocaine 2%Drug
Also called Local ( injectable ) anesthetic
10 ml of lidocaine 2% for perineal infiltration at the time of crowning
lidocaine prilocaine cream 15gmDrug
Also called EMLA cream
Lidocaine prilocaine cream, an eutectic mixture, is composed of Lidocaine-25 mg, Prilocaine-25 mg, Arlactone 289 -19 mg, Carbopol-10 mg, Sodium hydroxide to make a pH of 9.6 mg and purified water to produce l gram.
| Study group | Role | What they receive |
|---|---|---|
| Group I comprised 30 women who will receive 10 ml of lidocaine 2% | Active comparator | 10 ml of lidocaine 2% for perineal infiltration at the time of crowning Receives: Drug: 10 ml of lidocaine 2% |
| Group II will have lidocaine prilocaine cream 15gm application on the perineum | Active comparator | lidocaine-prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then an additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum Receives: Drug: lidocaine prilocaine cream 15gm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the Intervention on pain score during the repair of episiotomy
Efficacy of lidocaine-pridocaine cream in pain control for episiotomy incision and repair assessed by Visual Analogue Score VAS during episiotomy incision and repair where the minimum value is equal to zero which means no pain at all and the maximum value is equal to 10 and this means the worst pain ever.
Measured: 1 year
Secondary outcomes (2)
Effect of the Intervention on pain score during 6 weeks postpartum and dyspareunia after 6 weeks post partum
Pain score in the first week post-partum and 6 weeks post-partum also dysparunia after 6 weeks of delivery will be assessed by Customer Satisfaction Score or CSAT score, where the minimum value is very unsatisfied and associated with the highest degree of pain and the maximum value is very satisfied and this associated with the lowest degree of pain in 1 week and 6 weeks post patum
Measured: 1 year
Effect of the Intervention on perineal infection during 6 weeks postpartum
Detection of the infection rates 6 weeks post-partum as this is the period of perpurium when puerperal sepsis may develops.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Sep 2022
- Primary completion19 Jul 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Episiotomy WoundStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women. Group II will have lidocaine prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElHarty, Cairo University
- Investigators
- Ahmed S Alharty, MD, Study director, Cairo U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891132
- Sponsor's protocol ID
- MD-12-2023
- Status last verified
- Nov 2024
- First submitted
- 26 May 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not for IPD
Publications
Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn RA, Brodrick BS. 'Soothing the ring of fire': Australian women's and midwives' experiences of using perineal warm packs in the second stage of labour. Midwifery. 2009 Apr;25(2):e39-48. doi: 10.1016/j.midw.2007.08.002. Epub 2007 Nov 26.
PubMed 18031878East CE, Sherburn M, Nagle C, Said J, Forster D. Perineal pain following childbirth: prevalence, effects on postnatal recovery and analgesia usage. Midwifery. 2012 Feb;28(1):93-7. doi: 10.1016/j.midw.2010.11.009. Epub 2011 Jan 13.
PubMed 21236531El-Boghdadly K, Pawa A, Chin KJ. Local anesthetic systemic toxicity: current perspectives. Local Reg Anesth. 2018 Aug 8;11:35-44. doi: 10.2147/LRA.S154512. eCollection 2018.
PubMed 30122981Field T. Pregnancy and labor alternative therapy research. Altern Ther Health Med. 2008 Sep-Oct;14(5):28-34.
PubMed 18780582Simionescu R. [Stress reaction and anesthesia. The role of morphine agonists and antagonists]. Cah Anesthesiol. 1988 Jun-Jul;36(4):289-301. No abstract available. French.
PubMed 3048583Jorge LL, Feres CC, Teles VE. Topical preparations for pain relief: efficacy and patient adherence. J Pain Res. 2010 Dec 20;4:11-24. doi: 10.2147/JPR.S9492.
PubMed 21386951Kargar R, Aghazadeh-Nainie A, Khoddami-Vishteh HR. Comparison of the Effects of Lidocaine Prilocaine Cream (EMLA) and Lidocaine Injection on Reduction of Perineal Pain During Perineum Repair in Normal Vaginal Delivery. J Family Reprod Health. 2016 Mar;10(1):21-6.
PubMed 27385970Lullmann B, Leonhardt J, Metzelder M, Hoy L, Gerr H, Linderkamp C, Klein C, Grigull L. Pain reduction in children during port-a-cath catheter puncture using local anaesthesia with EMLA. Eur J Pediatr. 2010 Dec;169(12):1465-9. doi: 10.1007/s00431-010-1244-1. Epub 2010 Jul 10.
PubMed 20623233Sanders J, Peters TJ, Campbell R. Techniques to reduce perineal pain during spontaneous vaginal delivery and perineal suturing: a UK survey of midwifery practice. Midwifery. 2005 Jun;21(2):154-60. doi: 10.1016/j.midw.2004.12.003. Epub 2005 Mar 27.
PubMed 15878430Shahrahmani H, Kariman N, Jannesari S, Rafieian-Kopaei M, Mirzaei M, Ghalandari S, Shahrahmani N, Mardani G. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2018 Mar;32(3):522-530. doi: 10.1002/ptr.5999. Epub 2017 Dec 13.
PubMed 29235159Shavit I, Hadash A, Knaani-Levinz H, Shachor-Meyouhas Y, Kassis I. Lidocaine-based topical anesthetic with disinfectant (LidoDin) versus EMLA for venipuncture: a randomized controlled trial. Clin J Pain. 2009 Oct;25(8):711-4. doi: 10.1097/AJP.0b013e3181a689ec.
PubMed 19920722Greveling K, Prens EP, Liu L, van Doorn MBA. Non-invasive anaesthetic methods for dermatological laser procedures: a systematic review. J Eur Acad Dermatol Venereol. 2017 Jul;31(7):1096-1110. doi: 10.1111/jdv.14130. Epub 2017 Feb 8.
PubMed 28107576Walker SM. Neonatal pain. Paediatr Anaesth. 2014 Jan;24(1):39-48. doi: 10.1111/pan.12293. Epub 2013 Nov 13.
PubMed 24330444Zilbert A. Topical anesthesia for minor gynecological procedures: a review. Obstet Gynecol Surv. 2002 Mar;57(3):171-8. doi: 10.1097/00006254-200203000-00022.
PubMed 11889416
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effects of Lidocaine Prilocaine Cream and Lidocaine Injection on Reduction of Perineal Pain During Episiotomy and Perineum Repair in Vaginal Delivery: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05891132
- Acronym / sponsor ID
- MD-12-2023
- Conditions
- Episiotomy Wound
- Keywords
- Episiotomy, Anesthesia during labor, Injectable anesthetic, Topical anesthetic, Postpartum pain, Postpartum infection, Dyspareunia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 Jun 2023 (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.
The present study aims to compare the effects of lidocaine-prilocaine cream and lidocaine injection on the reduction of pain while doing and repairing episiotomy, controlling the pain in the post-partum period, and reduction the risk of infection in 6 weeks post partum and dyspareunia after 6 weeks post-partum.
Detailed description
Population of study \& disease condition:
The study will be conducted on 60 patients that will be admitted to the labor ward in the Department of Obstetrics \& Gynecology of a tertiary care center of Cairo University from Jan/2023 to Jan/2024 on. Primigravida women with singleton live pregnancy with cephalic presentation in the first stage of labor will be included in the study after approval by the Institutional Ethical Committee and obtaining an informed consent. Those with known allergy to lignocaine, altered mental status, request for epidural analgesia and hepatic disorders will be excluded from the study. The enrolled women will be divided into two groups by simple randomization with a 1:1 allocation ratio.
The following will be done to all participants:
- Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects.
- Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP).
- Thorough Clinical Examination: general (vital signs) and full obstetric examination.
- Obstetric ultrasonography: to confirm gestational age and the eligibility of the current pregnancy to participate in the study.
This will be a randomized controlled trial, randomization will be achieved by the following: the allocation treatment will be written on cards that will be sealed in sequentially numbered envelopes. The envelopes will be opened at the time of allocation after the enrolled participants will complete all baseline assessments. Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women of Group II will have lidocaine prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum. Lidocaine prilocaine cream, an eutectic mixture, is composed of Lidocaine-25 mg, Prilocaine-25 mg, Arlactone 289 -19 mg, Carbopol-10 mg, Sodium hydroxide to make a pH of 9.6 mg and purified water to produce l gram.
Fifteen grams of this cream will be applied as a thick layer (about 2 g/ 10 cm2 area) to the intact surface of the perineum and will be covered with an occlusive dressing (Kumar et al., 2015).
In previous study done by Nirmala et al., 2013 The mean pain scores in the study were comparable for both groups, in our study we will increase the dose and the intervals of the applied cream and we will write down the results regarding pain score and side effects.
At the time of crowning, the occlusive dressing and any residue of the cream will be removed and episiotomy will be done. The request for additional anesthetic agent (10 ml of 2% lidocaine solution for both groups) will be honored and recorded for both groups. And if the patient require additional analgesia during episiotomy (VAS more than 3) we will give additional anesthetic agent (10 ml of 2% lidocaine solution. After the repair of episiotomy, each patient will be asked to grade the severity of pain during perineal repair on a Visual Analog Scale (VAS). The far left will be labeled 'No pain' and the far right will be labelled as 'worst pain possible'. The subject will be asked to make a vertical mark on this line reflecting the severity of the pain.
The patients are followed 6 weeks post-partum at the OPC or by telephone call to check the pain score by using CAST score (Very satisfied - satisfied - not satisfied - dissatisfied).
Post-operative analgesics will include Paracetamol mainly and adjuvant NSAIDs as mentioned in the step ladder pain management by the WHO.
If any further analgesia needed we will use Pethidine as a rescue analgesic as it is safe after delivery but we will prescribe anti emetic with pethidine as it will induce nausea and vomiting.
Pain score during episiotomy repair will be the primary outcome of the study. Secondary outcome measures will include pain score in the first six weeks post-partum, dyspareunia after 6 weeks post-partum ( return to sexual life ) and reduction of the rate of wound infection.
Study location:
Kasr Al Ainy - Causality department (Department 10).
what does research involve? Human participants
Type of consent of study participants:
Written consent
Confidentiality of data:
- All study-related information will be stored at the study site.
Type of the study:
- Randomized Control Trial (RCT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women. Group II will have lidocaine prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum.
| Arm | Type | Receives |
|---|---|---|
| Group I comprised 30 women who will receive 10 ml of lidocaine 2% | Active comparator | Drug: 10 ml of lidocaine 2%10 ml of lidocaine 2% for perineal infiltration at the time of crowning |
| Group II will have lidocaine prilocaine cream 15gm application on the perineum | Active comparator | Drug: lidocaine prilocaine cream 15gmlidocaine-prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then an additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women candidate for VD ( ASA Ⅱ )
- Primigravida
- Pregnant more than 37 weeks (Term pregnancy).
- Singleton fetus.
- Cephalic presentation.
Key exclusion criteria (9 listed)
- More than or equal 1 previous CS and VBAC.
- Multiparous women.
- Pregnant less than 37 weeks
- Twin pregnancy.
- Not in active labor
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 |
|---|---|---|
| 10 ml of lidocaine 2%Also: Local ( injectable ) anesthetic10 ml of lidocaine 2% for perineal infiltration at the time of crowning | Drug | Group I comprised 30 women who will receive 10 ml of lidocaine 2% |
| lidocaine prilocaine cream 15gmAlso: EMLA creamLidocaine prilocaine cream, an eutectic mixture, is composed of Lidocaine-25 mg, Prilocaine-25 mg, Arlactone 289 -19 mg, Carbopol-10 mg, Sodium hydroxide to make a pH of 9.6 mg and purified water to produce l gram. | Drug | Group II will have lidocaine prilocaine cream 15gm application on the perineum |
Primary outcome
Effect of the Intervention on pain score during the repair of episiotomy
Time frame: 1 year
Efficacy of lidocaine-pridocaine cream in pain control for episiotomy incision and repair assessed by Visual Analogue Score VAS during episiotomy incision and repair where the minimum value is equal to zero which means no pain at all and the maximum value is equal to 10 and this means the worst pain ever.
2 secondary outcomes
Effect of the Intervention on pain score during 6 weeks postpartum and dyspareunia after 6 weeks post partum
Time frame: 1 year
Effect of the Intervention on perineal infection during 6 weeks postpartum
Time frame: 1 year
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 20 Nov 2024.
- Background: PubMed 18031878Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn RA, Brodrick BS. 'Soothing the ring of fire': Australian women's and midwives' experiences of using perineal warm packs in the second stage of labour. Midwifery. 2009 Apr;25(2):e39-48. doi: 10.1016/j.midw.2007.08.002. Epub 2007 Nov 26.
- Background: PubMed 21236531East CE, Sherburn M, Nagle C, Said J, Forster D. Perineal pain following childbirth: prevalence, effects on postnatal recovery and analgesia usage. Midwifery. 2012 Feb;28(1):93-7. doi: 10.1016/j.midw.2010.11.009. Epub 2011 Jan 13.
- Background: PubMed 30122981El-Boghdadly K, Pawa A, Chin KJ. Local anesthetic systemic toxicity: current perspectives. Local Reg Anesth. 2018 Aug 8;11:35-44. doi: 10.2147/LRA.S154512. eCollection 2018.
- Background: PubMed 18780582Field T. Pregnancy and labor alternative therapy research. Altern Ther Health Med. 2008 Sep-Oct;14(5):28-34.
- Background: PubMed 3048583Simionescu R. [Stress reaction and anesthesia. The role of morphine agonists and antagonists]. Cah Anesthesiol. 1988 Jun-Jul;36(4):289-301. No abstract available. French.
- Background: PubMed 21386951Jorge LL, Feres CC, Teles VE. Topical preparations for pain relief: efficacy and patient adherence. J Pain Res. 2010 Dec 20;4:11-24. doi: 10.2147/JPR.S9492.
- Background: PubMed 27385970Kargar R, Aghazadeh-Nainie A, Khoddami-Vishteh HR. Comparison of the Effects of Lidocaine Prilocaine Cream (EMLA) and Lidocaine Injection on Reduction of Perineal Pain During Perineum Repair in Normal Vaginal Delivery. J Family Reprod Health. 2016 Mar;10(1):21-6.
- Background: PubMed 20623233Lullmann B, Leonhardt J, Metzelder M, Hoy L, Gerr H, Linderkamp C, Klein C, Grigull L. Pain reduction in children during port-a-cath catheter puncture using local anaesthesia with EMLA. Eur J Pediatr. 2010 Dec;169(12):1465-9. doi: 10.1007/s00431-010-1244-1. Epub 2010 Jul 10.
- Background: PubMed 15878430Sanders J, Peters TJ, Campbell R. Techniques to reduce perineal pain during spontaneous vaginal delivery and perineal suturing: a UK survey of midwifery practice. Midwifery. 2005 Jun;21(2):154-60. doi: 10.1016/j.midw.2004.12.003. Epub 2005 Mar 27.
- Background: PubMed 29235159Shahrahmani H, Kariman N, Jannesari S, Rafieian-Kopaei M, Mirzaei M, Ghalandari S, Shahrahmani N, Mardani G. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2018 Mar;32(3):522-530. doi: 10.1002/ptr.5999. Epub 2017 Dec 13.
- Background: PubMed 19920722Shavit I, Hadash A, Knaani-Levinz H, Shachor-Meyouhas Y, Kassis I. Lidocaine-based topical anesthetic with disinfectant (LidoDin) versus EMLA for venipuncture: a randomized controlled trial. Clin J Pain. 2009 Oct;25(8):711-4. doi: 10.1097/AJP.0b013e3181a689ec.
- Background: PubMed 28107576Greveling K, Prens EP, Liu L, van Doorn MBA. Non-invasive anaesthetic methods for dermatological laser procedures: a systematic review. J Eur Acad Dermatol Venereol. 2017 Jul;31(7):1096-1110. doi: 10.1111/jdv.14130. Epub 2017 Feb 8.
- An investigation into the effect of alpha ointment (fundermol) on perineal pain relief following episiotomy in Nulliparous WomenLink provided by the sponsor.
- Who invented the episiotomy? On the history of the episiotomyLink provided by the sponsor.
- Comparison between lidocaine-prilocaine cream (EMLA) and Mepivacaine infiltration for pain relief during perineal repair after childbirth: A randomized trial. American Journal of Obstetrics and Gynecology, 201(2).Link provided by the sponsor.
- Kumar, M., Chawla, R., \& Goyal, M. (2015). Topical anesthesia. Journal of Anaesthesiology Clinical Pharmacology, 31(4), 450Link provided by the sponsor.
- Macarthur, A. J. \& Macarthur, C. Incidence, severity, and determinants of perineal pain after vaginal delivery: A prospective cohort study. American Journal of Obstetrics and Gynecology 191, 1199-1204 (2004).Link provided by the sponsor.
- Nirmala D, Ritu NA: ndalTopical lidocaine- prilocaine cream versus lignocaine infiltration for episiotomy repair: A randomized clinical trial. (2013). Journal of Clinical Research \& Governance.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Not for IPD
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Episiotomy, Platelet Rich Plasma (PRP)
Active, not recruiting
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
Pregnancy, Childbirth
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 S Alharty, MD study director
Cairo U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 ml of lidocaine 2% and lidocaine prilocaine cream 15gm in people with Episiotomy Wound, 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 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 20 Nov 2024. 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.
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?
Effect of the Intervention on pain score during the repair of episiotomy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891132, which also lists 14 linked publications.
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 20 Nov 2024.