Lidocaine-prilocaine Cream Versus Rectal Meloxicam on Relief of Post-episiotomy Pain

Assiut University

Status and phase: Completed; Phase 3

Conditions: Postpartum

Treatments: Drug: lidocaine-prilocaine cream; Drug: meloxicam rectal suppository

Study type: Interventional

Funder types: Other

Identifiers

NCT03146000

PEP

Details and patient eligibility

About

Postpartum perineal pain is a very common complaint. It can have negative consequences for mother and child including disability in daily functioning for the mother; for example, it can interfere in taking care of her infant and in breastfeeding. Early pain management is thus relevant to provide relief and prevent chronicity.

Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the first day after birth, of 75% in women with an intact perineum

Enrollment: 190 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Primiparas
2. Normal vaginal delivery
3. Mediolateral episiotomy
4. Ability to understand and the willingness to sign a written informed consent

Exclusion criteria

1. Patients who had postpartum hemorrhage
2. Patients who had manual removal of the placenta
3. Patients with contraindications to non steroidal drugs
4. Patients with a multiple perineal lacerations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

lidocaine-prilocaine

Experimental group

Description:

women will receive 5 mg lidocaine-prilocaine cream topically on the episiotomy line

Treatment:

Drug: lidocaine-prilocaine cream

meloxicam

Active Comparator group

Description:

women will receive one 15 mg meloxicam rectal suppository

Treatment:

Drug: meloxicam rectal suppository