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

NCT ID: NCT03146000

Last Updated: 2019-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-10-01

Brief Summary

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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

Detailed Description

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Conditions

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Postpartum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lidocaine-prilocaine

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

Group Type EXPERIMENTAL

lidocaine-prilocaine cream

Intervention Type DRUG

topical cream

meloxicam

women will receive one 15 mg meloxicam rectal suppository

Group Type ACTIVE_COMPARATOR

meloxicam rectal suppository

Intervention Type DRUG

suppository

Interventions

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lidocaine-prilocaine cream

topical cream

Intervention Type DRUG

meloxicam rectal suppository

suppository

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PEP

Identifier Type: -

Identifier Source: org_study_id

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