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CompletedNCT02883179LPPTUpdated Dec 13, 2017

Pain Relief During Repair of Postpartum Perineal Tears

A Phase 4 interventional study of lidocaine injection and lidocaine-prilocaine cream in Improving Quality of Life, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-13.

Sponsored by Assiut University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Improving Quality of Life
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Druglidocaine injection

    anhydrous solution

    Also known as: depocaine

  • Druglidocaine-prilocaine cream

    topical cream

    Also known as: pridocaine

06

What researchers measure

Primary outcomes

  1. Mean pain score during suture of perineal tears

    Time frame: 30 minutes

07

Study locations

1 site
  • Ahmed Abbas
    Assiut, Cairo 002, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02883179
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Abbas (Dr, Assiut University) — Principal investigator
First posted
Aug 30, 2016
Start date
Oct 2016
Primary completion
May 2017
Completion
Sep 2017
Last update
Dec 13, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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