Pain Relief During Repair of Postpartum Perineal Tears

Phase 4

Completed

• Conditions: Improving Quality of Life
• Interventions: Drug: lidocaine injection; Drug: lidocaine-prilocaine cream

• Registration Number: NCT02883179
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Study Start: 2016-10
• Primary Completion: 2017-05
• Study Completion: 2017-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine injection	lidocaine injection	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.
lidocaine-prilocaine cream	lidocaine-prilocaine cream	5-g dose of Lidocaine-prilocaine cream will be applied to the intact tissue around each tear for 5 minutes before suturing

Primary Outcome Measures

Name	Time	Method
Mean pain score during suture of perineal tears	30 minutes

Trial Locations

Locations (1)

Ahmed Abbas; 🇪🇬 Assiut, Cairo, Egypt