Topical lidocaine and pain reduction in natural childbirth

Efficacy and safety of lidocaine-prilocaine topical cream (XYLA-P) in reducing the intensity of episiotomy pain in normal vaginal delivery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231025059855N1

Enrollment

Registered

2023-12-23

Start date

2023-12-16

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Natural Vaginal Delivery. Single spontaneous delivery

Interventions

Intervention 1: Intervention group: Before episiotomy and during episiotomy repair, according to the standard protocol, the intervention group receives 2% injectable lidocaine in the form of 5 cc inje

Eligibility

Sex/Gender

Female

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: Healthy pregnant women with first natural delivery Gestational age between 37 and 41 weeks Episiotomy incision below 5 cm Patient satisfaction

Exclusion criteria

Exclusion criteria: Heavy bleeding during childbirth The need to use a vacuum during delivery Grade 3 and 4 perineal lacerations History of previous allergy to lidocaine or prilocaine

Design outcomes

Primary

Measure	Time frame
Intensity of pain. Timepoint: After the episiotomy and 1, 2, 4 and 24 hours after the episiotomy. Method of measurement: Visual Analogue Scale.;Patient satisfaction rate. Timepoint: After the episiotomy and 1, 2, 4 and 24 hours after the episiotomy. Method of measurement: Oral questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBita Shahrami

Tehran University of Medical Sciences

bshahrami@sina.tums.ac.ir+98 21 8490 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026