Lidocaine-Prilocaine Cream versus Placebo in Conjunction with Lidocaine Injection for Pain Relief during Episiotomy Repair after Normal Vaginal Delivery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250401009

Enrollment

Registered

2025-04-01

Start date

2023-08-22

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

The efficacy of lidocaine-prilocaine cream versus placebo in conjunction with lidocaine injection in relieving pain during episiotomy repair. Episiotomy, lidocaine-prilocaine cream, pain intensity, perineal repair

Interventions

The 5 g of lidocaine-prilocaine cream was applied around the perineal wound edge by the blinded operator who performed the episiotomy repair. After 5 minutes of application, the cream was removed, and

Experimental Drug,Placebo Comparator Other

Lidocaine-Prilocaine cream,Placebo

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. GA >= 37+0 weeks 2. Singleton pregnancy 3. Cephalic presentation 4. Age >= 18 years old 5. Undergo vaginal delivery with restrictive episiotomy 6. Second degree perineal tear

Exclusion criteria

Exclusion criteria: 1. operative vaginal delivery (forceps or vacuum extraction) 2. Manual removal of placenta 3. perineal wound hematoma 4. Postpartum hemorrhage 5. previous adverse reaction to local anesthesia 6. G-6-PD deficiency 7. compromised cardiac and pulmonary systems 8. hepatic diseases 9. congenital or idiopathic methemoglobinemia 10. difficulty communicating in Thai language

Design outcomes

Primary

Measure	Time frame
Pain score during perineal skin repair Visual analogue scale	—

Secondary

Measure	Time frame
Pain score during lidocaine injection Visual analogue scale,Pain score during vaginal mucosa repair Visual analogue scale,Pain score during perineal muscle repair Visual analogue scale,Pain score at 1 hour after perineal repair Visual analogue scale,Need for additional anesthesia during episiotomy repair record when the additional anesthesia was needed,Patient satisfaction after finish episiotomy repair Patient reported outcome using 5-point Likert scale,Perineal wound complication at 1 week after delivae Patient reported outcome using a questionnaire interview	—

Measure

Time frame

Pain score during lidocaine injection Visual analogue scale,Pain score during vaginal mucosa repair Visual analogue scale,Pain score during perineal muscle repair Visual analogue scale,Pain score at 1 hour after perineal repair Visual analogue scale,Need for additional anesthesia during episiotomy repair record when the additional anesthesia was needed,Patient satisfaction after finish episiotomy repair Patient reported outcome using 5-point Likert scale,Perineal wound complication at 1 week after delivae Patient reported outcome using a questionnaire interview

—

Countries

Thailand

Contacts

Public ContactLalita Wongvivattanakarn

Khon Kaen Hospital

jernlalita.wong@gmail.com0885617350

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026