Pain Relief During Repair of Postpartum Perineal Tears (LPPT)

Assiut University

Status and phase: Completed; Phase 4

Conditions: Improving Quality of Life

Treatments: Drug: lidocaine injection; Drug: lidocaine-prilocaine cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02883179

LPPT

Details and patient eligibility

About

The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal tears.

Enrollment: 144 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Gestational age > 37 weeks
2. Uncomplicated pregnancy
3. Single vertex fetus
4. Normal vaginal delivery
5. Women who will accept to participate in the study

Exclusion criteria

1. Women received epidural analgesia
2. Women required episiotomy
3. Women with intact perineum
4. Operative vaginal delivery
5. Allergy to the used drugs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

lidocaine injection

Active Comparator group

Description:

5 mL of 2% lidocaine anhydrous solution (Depocaine) will be injected slowly along the lines of the edges of the perineal tears after delivery, with frequent aspirations to avoid intravascular injection.

Treatment:

Drug: lidocaine injection

lidocaine-prilocaine cream

Experimental group

Description:

5-g dose of Lidocaine-prilocaine cream will be applied to the intact tissue around each tear for 5 minutes before suturing

Treatment:

Drug: lidocaine-prilocaine cream