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

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
EMLA CREAM 5 mg
LIDOCAINE 1 %
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring EMLA CREAM, LIDOCAINE INFILTERATION, PAIN RELIEF

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams university Maternity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EMLA CREAM

LIDOCAINE INFILTERATION

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

POSTOPERATIVE PAIN ACCORDING TO VAS

Full Information

First Posted
January 21, 2015
Last Updated
September 11, 2015
Sponsor
Ain Shams Maternity Hospital
Collaborators
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02549105
Brief Title
Lidocaine-Prilocaine Cream (EMLA) Topical Application Versus Wound Infiltration With Lidocaine After Cesarean Section
Official Title
A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And Wound Infiltration With Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
Collaborators
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
EMLA CREAM, LIDOCAINE INFILTERATION, PAIN RELIEF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMLA CREAM
Arm Type
Active Comparator
Arm Description
EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS
Arm Title
LIDOCAINE INFILTERATION
Arm Type
Active Comparator
Arm Description
LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS
Intervention Type
Drug
Intervention Name(s)
EMLA CREAM 5 mg
Other Intervention Name(s)
EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25
Intervention Description
EMLA CREAM APPLICATION FOR WOUND AFTER CS
Intervention Type
Drug
Intervention Name(s)
LIDOCAINE 1 %
Other Intervention Name(s)
XYLOCAINE
Intervention Description
LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS
Primary Outcome Measure Information:
Title
TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS
Time Frame
6 H
Secondary Outcome Measure Information:
Title
POSTOPERATIVE PAIN ACCORDING TO VAS
Time Frame
24 H

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18 and 40 years. Patient American Society of Anesthesiologists physical status І or П. Gestational age of pregnancy of 37w or more. Patient have no previous section or have 1or 2 previous sections. Patient having no medical disorders. Patient with no obstetrical complications. Exclusion Criteria: age below18 or above 40. Women American Society of Anesthesiologists physical status ш or more. Women having more than 2 previous cesarean section. Women receive cardio vascular drugs or having history of cardio vascular disease. Women with Medical disorders with pregnancy as diabetes milletus. Women having obstetrical complications as antepartum hemorrhage, pre-eclampsia or eclampsia. Women having metabolic, hormonal, respiratory, renal and hepatic disease. Women with any severe allergic condition or severe asthma. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HANY A IBRAHIM, MBBCH
Phone
01220034468
Email
DR.HANY_AYAD@YAHOO.COM
First Name & Middle Initial & Last Name or Official Title & Degree
AHMED M MAMDOUH, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MAGED R ABO SAEDA, MD
Organizational Affiliation
AIN SHAMS MATERNAL HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams university Maternity hospital
City
Cairo
State/Province
Abbasya
ZIP/Postal Code
11821
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maged R Aboseda, professor
Phone
00201069190707
Email
ahmadhassan376@gmail.com

12. IPD Sharing Statement

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

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