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Status unknownNCT02549105Updated Sep 15, 2015

Lidocaine-Prilocaine Cream (EMLA) Topical Application Versus Wound Infiltration With Lidocaine After Cesarean Section

A Phase 4 interventional study of EMLA CREAM 5 mg and LIDOCAINE 1 % in Post Operative Pain, sponsored by Ain Shams Maternity Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Ain Shams Maternity Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.

Read the detailed description

The purpose of this study is to compare the effectiveness of topically applied lidocaine-prilocaine (EMLA) cream with local anesthetic (lidocaine) infiltration on post-cesarean section pain.

Research Question:

Is lidocaine-prilocaine (EMLA) cream application effective as compared to local anesthetic (lidocaine) infiltration on post-caesarean section pain?

Research Hypothesis:

Lidocaine-prilocaine (EMLA) cream application is effective in post_caesarean section pain as compared to local anesthetic (lidocaine) infiltration.

Clinical Application :

Topical Lidocaine-prilocaine (EMLA) cream could be applied frequent times postoperatively, unlike infiltration with local anesthetic.

02

Conditions studied

  • Post Operative Pain

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Keywords

  • EMLA CREAM
  • LIDOCAINE INFILTERATION
  • PAIN RELIEF
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age between 18 and 40 years.
  2. Patient American Society of Anesthesiologists physical status І or П.
  3. Gestational age of pregnancy of 37w or more.
  4. Patient have no previous section or have 1or 2 previous sections.
  5. Patient having no medical disorders.
  6. Patient with no obstetrical complications.

Exclusion criteria

Exclusion Criteria:

  1. age below18 or above 40.
  2. Women American Society of Anesthesiologists physical status ш or more.
  3. Women having more than 2 previous cesarean section.
  4. Women receive cardio vascular drugs or having history of cardio vascular disease.
  5. Women with Medical disorders with pregnancy as diabetes milletus.
  6. Women having obstetrical complications as antepartum hemorrhage, pre-eclampsia or eclampsia.
  7. Women having metabolic, hormonal, respiratory, renal and hepatic disease.
  8. Women with any severe allergic condition or severe asthma.
  9. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    EMLA CREAM

    EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS

    Drug: EMLA CREAM 5 mg

  • Active comparator
    LIDOCAINE INFILTERATION

    LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS

    Drug: LIDOCAINE 1 %

Interventions

  • DrugEMLA CREAM 5 mg

    EMLA CREAM APPLICATION FOR WOUND AFTER CS

    Also known as: EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25

  • DrugLIDOCAINE 1 %

    LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS

    Also known as: XYLOCAINE

06

What researchers measure

Primary outcomes

  1. TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS

    Time frame: 6 H

Secondary outcomes

  1. POSTOPERATIVE PAIN ACCORDING TO VAS

    Time frame: 24 H

07

Study locations

1 of 1 sites recruiting
  • Ain Shams university Maternity hospital
    Cairo, Abbasya 11821, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02549105
Lead sponsor
Ain Shams Maternity Hospital
Collaborators
Ain Shams University
Responsible party
HANY AYAD IBRAHIM (RESIDENT DOCTOR, Ain Shams Maternity Hospital) — Principal investigator
First posted
Sep 15, 2015
Start date
Oct 2014
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Sep 15, 2015

Study contacts

HANY A IBRAHIM, MBBCH
Contact
DR.HANY_AYAD@YAHOO.COM
01220034468
AHMED M MAMDOUH, MD
Contact
MAGED R ABO SAEDA, MD
principal investigator · AIN SHAMS MATERNAL HOSPITAL

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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