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

Study Overview
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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.

Official Title
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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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: EMLA CREAM 5 mg
* Drug: LIDOCAINE 1 %


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EMLA CREAM<br>EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS | Drug: EMLA CREAM 5 mg<br>* EMLA CREAM APPLICATION FOR WOUND AFTER CS<br>* Other names: EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25;|
| Active Comparator: LIDOCAINE INFILTERATION<br>LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS | Drug: LIDOCAINE 1 %<br>* LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS<br>* Other names: XYLOCAINE;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POSTOPERATIVE PAIN ACCORDING TO VAS |  | 24 H | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMLA CREAM, LIDOCAINE INFILTERATION, PAIN RELIEF