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

September 11, 2015 updated by: HANY AYAD IBRAHIM, Ain Shams Maternity Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasya
      • Cairo, Abbasya, Egypt, 11821
        • Recruiting
        • Ain Shams University Maternity Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
EMLA CREAM APPLICATION FOR WOUND AFTER CS
Other Names:
  • EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25
Active Comparator: LIDOCAINE INFILTERATION
LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS
Drug: LIDOCAINE 1 %
LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS
Other Names:
  • XYLOCAINE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS
Time Frame: 6 H
6 H

Secondary Outcome Measures

Outcome Measure
Time Frame
POSTOPERATIVE PAIN ACCORDING TO VAS
Time Frame: 24 H
24 H

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Collaborators

Ain Shams University

Investigators

  • Principal Investigator: MAGED R ABO SAEDA, MD, AIN SHAMS MATERNAL HOSPITAL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 11, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ain Shams MH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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