Clinical trial NCT05891132: Comparison Between Lidocaine Prilocaine Cream and Lidocaine Injection on Pain Control During Episiotomy.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episiotomy Wound
Keywords: Episiotomy
Anesthesia during labor
Injectable anesthetic
Topical anesthetic
Postpartum pain
Postpartum infection
Dyspareunia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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)

Eligibility criteria: Inclusion Criteria:

1. Pregnant women candidate for VD ( ASA Ⅱ )
2. Primigravida
3. Pregnant more than 37 weeks (Term pregnancy).
4. Singleton fetus.
5. Cephalic presentation.
6. In first stage of labor.

Exclusion Criteria:

1. More than or equal 1 previous CS and VBAC.
2. Multiparous women.
3. Pregnant less than 37 weeks
4. Twin pregnancy.
5. Not in active labor
6. allergy to lignocaine
7. altered mental status
8. request for epidural analgesia
9. Hepatic impairment.

Primary outcomes:
measure: Effect of the Intervention on pain score during the repair of episiotomy
timeFrame: 1 year
Secondary outcomes:
measure: Effect of the Intervention on pain score during 6 weeks postpartum and dyspareunia after 6 weeks post partum
timeFrame: 1 year
measure: Effect of the Intervention on perineal infection during 6 weeks postpartum
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo U
name: Ahmed S Alharty, MD
role: STUDY_DIRECTOR
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