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Lidocaine-prilocaine Cream vs Lidocaine Injection for Postpartum Perineal Tears
NCT02883179Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2016
- Primary completion
- May 2017
- Countries
- 1
- Sponsor
- Assiut University
- Modality
- Small Molecules, Drug Delivery Systems
- Conditions
- perineal tear
01
Overview
Phase 4, randomised, open-label trial of lidocaine + prilocaine in perineal tear (2 arms), sponsored by Assiut University. Primary endpoint: Mean pain score during suture of perineal tears at 30 minutes. Started Oct 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Lidocaine Injection
5 mL of 2% lidocaine anhydrous solution injected along tear edges
Lidocaine-prilocaine Cream
5g of cream applied topically for 5 minutes before suturing
03
Who it enrols
Parous women with uncomplicated pregnancy, single vertex fetus, normal vaginal delivery, gestational age > 37 weeks, and first or second degree perineal tears. Excludes those with epidural analgesia, episiotomy, intact perineum, operative vaginal delivery, or allergy to used drugs.
04
Endpoints
Primary
Mean pain score during suture of perineal tears
Secondary
Participants' satisfaction
Need for additional anesthesia
Duration of perineal repair
Rate of adverse effects
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