NCT02883179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

August 22, 2016

Last Update Submit

December 12, 2017

Conditions

Improving Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during suture of perineal tears

    30 minutes

Study Arms (2)

lidocaine injection

ACTIVE COMPARATOR

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

lidocaine-prilocaine cream

EXPERIMENTAL

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

Interventions

lidocaine injectionDRUG

anhydrous solution

Also known as: depocaine
lidocaine injection
lidocaine-prilocaine creamDRUG

topical cream

Also known as: pridocaine
lidocaine-prilocaine cream

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age \> 37 weeks
  • Uncomplicated pregnancy
  • Single vertex fetus
  • Normal vaginal delivery
  • Women who will accept to participate in the study

You may not qualify if:

  • Women received epidural analgesia
  • Women required episiotomy
  • Women with intact perineum
  • Operative vaginal delivery
  • Allergy to the used drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 30, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

December 13, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

Locations

EG(1)