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

NCT ID: NCT02549105

Last Updated: 2015-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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EMLA CREAM

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

Group Type ACTIVE_COMPARATOR

EMLA CREAM 5 mg

Intervention Type DRUG

EMLA CREAM APPLICATION FOR WOUND AFTER CS

LIDOCAINE INFILTERATION

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

Group Type ACTIVE_COMPARATOR

LIDOCAINE 1 %

Intervention Type DRUG

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

Interventions

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EMLA CREAM 5 mg

EMLA CREAM APPLICATION FOR WOUND AFTER CS

Intervention Type DRUG

LIDOCAINE 1 %

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

Intervention Type DRUG

Other Intervention Names

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EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25 XYLOCAINE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role collaborator

Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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HANY AYAD IBRAHIM

RESIDENT DOCTOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MAGED R ABO SAEDA, MD

Role: PRINCIPAL_INVESTIGATOR

AIN SHAMS MATERNAL HOSPITAL

Locations

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Ain Shams university Maternity hospital

Cairo, Abbasya, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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HANY A IBRAHIM, MBBCH

Role: CONTACT

01220034468

AHMED M MAMDOUH, MD

Role: CONTACT

Facility Contacts

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Maged R Aboseda, professor

Role: primary

00201069190707

Other Identifiers

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Ain Shams MH

Identifier Type: -

Identifier Source: org_study_id

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