Pain Relief During Repair of Postpartum Perineal Tears (LPPT)

Topical Lidocaine-prilocaine Cream Versus Lidocaine Infiltration for Pain Relief During Repair of Postpartum Perineal Tears: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Improving Quality of Life
• Intervention / Treatment: Drug: lidocaine injection; Drug: lidocaine-prilocaine cream

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: lidocaine injection; anhydrous solution; Other Names: depocaine
Experimental: 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	Drug: lidocaine-prilocaine cream; topical cream; Other Names: pridocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean pain score during suture of perineal tears	30 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Combined; Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
• Other Study ID Numbers: LPPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No