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

Phase 4

• Conditions: Post Operative Pain
• Interventions: Drug: EMLA CREAM 5 mg; Drug: LIDOCAINE 1 %

• Registration Number: NCT02549105
• Lead Sponsor: Ain Shams Maternity Hospital

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-21
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-15
• Last Update Posted: 2015-09-15
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMLA CREAM	EMLA CREAM 5 mg	EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS
LIDOCAINE INFILTERATION	LIDOCAINE 1 %	LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS

Primary Outcome Measures

Name	Time	Method
TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS	6 H

Secondary Outcome Measures

Name	Time	Method
POSTOPERATIVE PAIN ACCORDING TO VAS	24 H

Trial Locations

Locations (1)

Ain Shams university Maternity hospital; 🇪🇬 Cairo, Abbasya, Egypt