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

NCT03146000 | Completed Phase 3

• 1 other identifier: PEP
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postpartum

Outcome Measures

Primary Outcomes (1)

• The mean difference of visual analog scale after delivery

  the scale is graded from 0 to 10

  immediately

Study Arms (2)

lidocaine-prilocaine

EXPERIMENTAL

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

Drug: lidocaine-prilocaine cream

meloxicam

ACTIVE COMPARATOR

women will receive one 15 mg meloxicam rectal suppository

Drug: meloxicam rectal suppository

Interventions

lidocaine-prilocaine cream DRUG

topical cream

lidocaine-prilocaine

meloxicam rectal suppository DRUG

suppository

meloxicam

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primiparas
• Normal vaginal delivery
• Mediolateral episiotomy
• Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

• Patients who had postpartum hemorrhage
• Patients who had manual removal of the placenta
• Patients with contraindications to non steroidal drugs
• Patients with a multiple perineal lacerations

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: May 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: October 1, 2018
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)