Comparison Between Lidocaine Prilocaine Cream and Lidocaine Injection on Pain Control During Episiotomy.

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05891132

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 and dyspareunia in 6 weeks post-partum.

Condition or Disease	Intervention/Treatment	Phase
Episiotomy Wound	Drug: 10 ml of lidocaine 2% Drug: lidocaine prilocaine cream 15gm	N/A

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 double blinded study, blindness 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 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 labelled '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 pain.

The patients are followed 6-week post-partum at the OPC or by telephone call to check the pain score by using (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 analgesics 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 and reduction of the rate of wound infection.

Study location:

Kasr Al Ainy - Causality department (Department 10).

Inclusion criteria:

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

Exclusion criteria:

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
altered mental status
request for epidural analgesia
Hepatic impairment.

Intervention:

Injection of lidocaine in the episiotomy site, Application of lidocaine-pridocaine cream at the site of episiotomy.

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)

Outcomes:

The primary outcome:

Efficacy of lidocaine-pridocaine cream in pain control for episiotomy incision and repair assessed by VAS during episiotomy incision and repair.

The secondary outcomes:

Pain score and dyspareunia in the first week post-partum and 6 weeks post-partum will be assessed by degree of satisfaction, the time period of 1 week and 6 weeks were selected based on study described by Macarthur et al., 2004 that stated that The frequency of perineal pain was 92% on day 1 post-partum, dropping to 61% on day 7, and 7% at 6 weeks post-partum.
Detection of the infection rates 6 weeks post-partum as this is the period of perpurium when puerperal sepsis may develops.

Possible Risk:

No risk detected.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant)

Masking Description:

This will be a double-blinded study, blindness 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.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I comprised 30 women who will receive 10 ml of lidocaine 2% 10 ml of lidocaine 2% for perineal infiltration at the time of crowning	Drug: 10 ml of lidocaine 2% 10 ml of lidocaine 2% for perineal infiltration at the time of crowning Other Names: Local ( injectable ) anesthetic
Active Comparator: Group II will have lidocaine prilocaine cream 15gm application on the perineum 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	Drug: lidocaine prilocaine cream 15gm 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. Other Names: EMLA cream

Arm

Intervention/Treatment

Active Comparator: Group I comprised 30 women who will receive 10 ml of lidocaine 2%

10 ml of lidocaine 2% for perineal infiltration at the time of crowning

Drug: 10 ml of lidocaine 2%

10 ml of lidocaine 2% for perineal infiltration at the time of crowning

Other Names:

Local ( injectable ) anesthetic

Active Comparator: Group II will have lidocaine prilocaine cream 15gm application on the perineum

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

Drug: lidocaine prilocaine cream 15gm

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.

Other Names:

EMLA cream

Outcome Measures

Primary Outcome Measures

Effect of the Intervention on pain score during the repair of episiotomy [1 year]
Efficacy of lidocaine-pridocaine cream in pain control for episiotomy incision and repair assessed by VAS during episiotomy incision and repair.

Secondary Outcome Measures

Effect of the Intervention on pain score and dyspareunia during 6 weeks postpartum [1 year]
Pain score and dyspareunia in the first week post-partum and 6 weeks post-partum will be assessed by degree of satisfaction, the time period of 1 week and 6 weeks .
Effect of the Intervention on perineal infection during 6 weeks postpartum [1 year]
Detection of the infection rates 6 weeks post-partum as this is the period of perpurium when puerperal sepsis may develops.